Neale Richmond, Minister of State for business, employment & retail cuts the ribbon with Katarina, CEO of Tech startup Bonafi  and members of the company at Oaktree Business Park, Trim, Co. Meath
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BONAFI ANNOUNCES LAUNCH AND OPENING OF MEATH OFFICE

BONAFI ANNOUNCES LAUNCH AND OPENING OF MEATH OFFICE

17 November 2023Minister of State for Business, Employment and Retail Neale Richmond TD today officially opened the new office space of life science technology company, Bonafi, in Trim in County Meath. Bonafi Limited, a pioneer in compliance technology for the life sciences sector, today also announced the launch of its ground-breaking platform, set to transform the pharmaceutical supply chain’s approach to customer and supplier qualifications.

With a current team of seven in Meath and a global footprint extending to Sweden, Spain, and Bulgaria, Bonafi aims to further expand its workforce with 10 additional hires in Meath over the next 12 months.

With recent funding achievements, including a €200K investment from Enterprise Ireland, Bonafi is set for a trajectory of swift and sustainable expansion. The board has been strengthened with the strategic appointments of Anne Nolan, Ken O’Connell, and Dave Shanahan, bringing a wealth of expertise in pharmaceuticals, finance, and global business development that aligns with Bonafi’s mission to be at the forefront of pharma compliance management.

Speaking at the event Minister Neale Richmond, highlighted the government’s endorsement of Bonafi’s contribution and commitment to regional employment and technological innovation. “I am delighted to join Bonafi today to celebrate the opening of their new office space and their €200,000 investment from Enterprise Ireland. This Government is prioritising balanced regional development and it is companies like Bonafi, who will create 10 new jobs in 2024 here in Trim, who are paving the way for this growth in our regions. Launching a high-potential start up in Meath, particularly one in the regtech sector, allows for access to a wide pool of talented workers, but also supports the local economy. Today’s announcement is good for Meath, good for the Mid-East, and good for the regtech sector. I am sure that Bonafi will pave the way for other companies to launch here in Meath as well. The Government, through Enterprise Ireland, looks forward to help Bonafi continue to grow and create jobs into the future.”

CEO and Founder Katarina Antill speaks to the heart of Bonafi’s mission, stating, “Today marks a milestone for Bonafi. Our product launch, the opening of the Trim office and the enhanced leadership team underscore our resolve to set the gold standard in the industry. We’re grateful for the trust our investors have placed in us and excited about the opportunities ahead.

Anne Nolan, newly appointed Chairperson, remarked on the occasion, “The Bonafi system is a game changer for the pharmaceutical industry and will undoubtedly play a huge role in supporting the efficiency, integrity and safety of the pharma supply chain globally. I would encourage all companies to examine how Bonafi can help automate and update the laborious, time consuming and costly exercise in good distribution practice. I wish Katarina and all her team every success in the months and years ahead as they roll out this marvellous and user-friendly initiative.”

Anne Lanigan, Divisional Manager, Technology and Services, Enterprise Ireland said: “Bonafi is a regtech high potential start-up bringing innovation and adaptability to the critical area of compliance in the pharmaceutical industry. Enterprise Ireland is proud to support the company on its scaling journey and I’d like to congratulate the team on their significant achievements to date. Under the leadership of CEO and Founder Katarina Antill, we are confident that Bonafi can go from strength-to-strength and make its mark offering a highly innovative deep-tech solution to the pharma sector globally.

Ends

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Java Software Engineer – Ireland

Careers at Bonafi

Java Software Engineer

Bulgaria – Full time – Software development – Experienced

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Introduction

Bonafi Bonafi is a growing compliance start-up in the pharmaceutical industry. Our mission is to help companies manage the end-to-end qualification cycle of their customers and suppliers through automation and digitalization. At Bonafi, we value diversity and respect in the workplace. We believe that diverse perspectives and backgrounds foster innovation and drive growth. It is a hybrid role, based in County Meath Ireland.

Overview of the job’s responsibilities:

Bonafi is seeking an experienced software developer who can contribute to innovative solutions. A Software Developer at Bonafi will work hand-in-hand with our designers, QA Teams, and stakeholders to deliver a timely, high-quality product.

Who will love this job?

We believe that this job is for someone who would like the chance to make a big individual impact with autonomy and responsibility. 

The ideal candidate is a self-motivated, multi-tasker, and demonstrated team player. Someone who thrives in a startup environment and can contribute to original ideas and take ownership. 

You will be a developer responsible for the development of new software products and help shape our future solutions. 

What you’ll be responsible for:
  • Writing clean, high-quality, high-performance, maintainable code
  • Technical documentation
  • Develop and support software including applications, database integration, interfaces, and new functionality enhancements
  • Coordinate cross-functionally to insure project meets business objectives and compliance standards
  • Support test and deployment of new products and features
  • Participate in code reviews

What we look for in a candidate: 

  • Fluent in English 
  • The candidate must live in Ireland and must be allowed to work in Ireland permanently.
  • Effective communication skills are essential. 
  • Experience with Agile or Scrum software development methodologies 
  • Ability to multi-task, organize, and prioritize work 
  • 3+ years of relevant work experience 
  • Professional expertise in Object-Oriented Design and Database Design 
  • Professional experience developing applications using Java, Spring Boot, Hibernate, Git, AWS (Amazon Web Services)  
  • Knowledge of Vue (or another UI Framework) & Python an advantage 
  • Some experience with infrastructure technologies such as Docker & Kubernetes 
  • Experience documenting systems, processes, and solutions 
  • Professional experience designing and developing APIs via REST and JSON  
  • Experience using SQL and NoSQL databases 
  • Experience working with Pharma GxP software is a bonus 
  • Professional Qualifications or bachelor’s degree in Computer Science (or related field) an advantage. 

Posted 17 Feb 2023

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Quality Assurance Associate – Ireland

Careers at Bonafi

Quality Assurance Associate - Ireland

Bulgaria – Full time – Quality Assurance Associate- Experienced

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Introduction

Bonafi is a fast-growing compliance tech start-up company in the pharmaceutical industry. Our mission is to support companies manage the end-to-end qualification cycle of their customers and suppliers through automation and digitalization.  

At Bonafi, we value diversity, integrity, and respect within the workplace. We believe that diverse perspectives and backgrounds foster innovation and drive growth.  

Overview of the job’s responsibilities:

Bonafi is seeking an experienced Quality Assurance Associate who will contribute to strengthening our Quality Management System and company. The Quality Assurance Associate at Bonafi will work hand-in-hand with our Development Operations Teams, QA Testers, and other stakeholders to deliver a timely, high-quality compliant SAAS product.  

Who will love this job?

We believe that this job is for someone who  

  • will take the chance and make an individual impact through autonomy and responsibility 
  • is a self-motivated, multi-tasker, proven team player within cross-functional teams 
  • thrives in a start-up environment and can contribute to original ideas  
  • is good at rolling up their sleeves to achieve results in a start-up environment  
  • enjoys Critical thinking/evaluation of process problems skills 
  • who has strong work ethic and the ability to work independently 

The ideal candidate should enjoy improving how things are done, as well as making sure they get done 

 What you’ll contribute to and be responsible for:  

  • Collaboration with the Head of Quality Assurance and other Department Managers to enhance internal compliance, through continuous improvements
  • Supporting the setup and shaping of our Quality Management Systems  
  • Preparing for our ISO9001-2015 Certification and maintaining compliance within the ISO9001 framework   
  • Writing and/or review of documentation that supports GxP activities for accuracy, completeness, compliance, and user-friendliness, e.g., SOPs, instructions, validation documentation    
  • Leading, coordinating, or performing deviation investigations  
  • Management / Implementation of Corrective and Preventive Measures, Change Controls, and Software Life Cycle Controls. 
  • Providing training to other parts of the business on the Quality Management Systems 
  • Participating in internal and external audits and implementing any resulting recommendations/actions 
  • Reviewing and evaluating customer complaints; supporting root cause determination and risk assessments as necessary  
  • Consideration of General Data Protection Regulation (GDPR) in documentation 
  • To undertake any further duties, from time to time as may be reasonably required  
  • Successful, timely completion of goals and objectives that strengthen the Organisation.  
  • Progress reporting against deadlines 

What we look for in a candidate:  

Essential  
  • Understanding of relevant quality regulations, such as ISO 9001 and GxP e.g., Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP)  
  • At least two years of experience in Quality Assurance within a regulated industry, particularly in pharmaceutical/life science industries.  
  • Qualification, preferably in a related field.  
  • Proficiency with Microsoft Office, including Word, Excel, and PowerPoint, is necessary for performing essential job functions and analysing data.  
  • Strong written, oral, and presentation skills in English, as well as the ability to work well in a team and possess critical thinking skills 
Desired: 
  • Knowledge of GAMP – Good Automation Management Systems  
  • Experience in working with quality compliance software and/or Computer Software Validation 

Posted 06 January 2023

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QA Tester

Careers at Bonafi

QA Tester

Bulgaria – Full time – QA Testing – Experienced

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Introduction

Bonafi is a growing compliance start-up in the pharmaceutical industry. Our mission is to help companies manage the end-to-end qualification cycle of their customers and suppliers through automation and digitalization. At Bonafi, we value diversity and respect in the workplace. We believe that diverse perspectives and backgrounds foster innovation and drive growth. 

Overview of the job’s responsibilities:

We are seeking a highly motivated QA Tester to join our growing team. A QA Tester at Bonafi will work together with our developers, the QA/Compliance team, and stakeholders to deliver a timely, high-quality product.  

Who will love this job?

We believe that this job is for someone who would like the chance to make a big individual impact with autonomy and responsibility. 

The ideal candidate is a self-motivated, multi-tasker, and demonstrated team player. Someone who thrives in a startup environment and can contribute to original ideas and take ownership. 

You will be responsible for designing and executing test plans, identifying and reporting defects, and collaborating with development teams to ensure the timely resolution of issues. 

What you will be responsible for: 

  • Review and analyze system specifications 
  • Develop effective strategies and test plans 
  • Writing automated test scripts 
  • Execute test cases (manual and automated) and analyze results 
  • Evaluate product behavior according to specifications 
  • Create logs to document testing phases and defects 
  • Report bugs and errors to development teams 
  • Help troubleshoot issues 
  • Conduct post-release/ post-implementation testing 
  • Work with cross-functional teams to ensure quality throughout the software development lifecycle 

What we look for in a candidate: 

  • Strong attention to detail 
  • Ability to work independently and as part of a team 
  • Experience with writing automated tests 
  • Experience with defect-tracking systems 
  • Effective communication and collaboration skills  
  • Proven experience as a Quality Assurance Tester or similar role 
  • Experience in QA methodology 
  • Familiarity with Agile frameworks and regression testing 
  • Ability to document and troubleshoot errors 
  • Working knowledge of test management software (e.g., qTest, Zephyr) and SQL 
  • Analytical mind and problem-solving aptitude 
  • Strong organizational skills 
  • Formal Qualifications in Computer Science, Engineering, or a related field an advantage 

 

Posted 05 January 2023

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Multiethnic modern business team developing the company's strategy at the office

Software Developer

Careers at Bonafi

Software Developer

Bulgaria – Full time – Software development – Experienced

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Introduction

Bonafi Bonafi is a growing compliance start-up in the pharmaceutical industry. Our mission is to help companies manage the end-to-end qualification cycle of their customers and suppliers through automation and digitalization. At Bonafi, we value diversity and respect in the workplace. We believe that diverse perspectives and backgrounds foster innovation and drive growth. 

Overview of the job’s responsibilities:

Bonafi is seeking an experienced software developer who can contribute to innovative solutions. A Software Developer at Bonafi will work hand-in-hand with our designers, QA Teams, and stakeholders to deliver a timely, high-quality product.

Who will love this job?

We believe that this job is for someone who would like the chance to make a big individual impact with autonomy and responsibility. 

The ideal candidate is a self-motivated, multi-tasker, and demonstrated team player. Someone who thrives in a startup environment and can contribute to original ideas and take ownership. 

You will be a developer responsible for the development of new software products and help shape our future solutions. 

What you’ll be responsible for:
  • Writing clean, high-quality, high-performance, maintainable code
  • Technical documentation
  • Develop and support software including applications, database integration, interfaces, and new functionality enhancements
  • Coordinate cross-functionally to insure project meets business objectives and compliance standards
  • Support test and deployment of new products and features
  • Participate in code reviews

What we look for in a candidate: 

  • Fluent in English 
  • Effective communication skills are essential. 
  • Experience with Agile or Scrum software development methodologies 
  • Ability to multi-task, organize, and prioritize work 
  • 3+ years of relevant work experience 
  • Professional expertise in Object-Oriented Design and Database Design 
  • Professional experience developing applications using Java, Spring Boot, Hibernate, Git, AWS (Amazon Web Services)  
  • Knowledge of Vue (or another UI Framework) & Python an advantage 
  • Some experience with infrastructure technologies such as Docker & Kubernetes 
  • Experience documenting systems, processes, and solutions 
  • Professional experience designing and developing APIs via REST and JSON  
  • Experience using SQL and NoSQL databases 
  • Experience working with Pharma GxP software is a bonus 
  • Professional Qualifications or bachelor’s degree in Computer Science (or related field) an advantage. 

Posted 05 January 2023

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National Startup Awards 2021

Bonafi takes Bronze in the National Startup Awards 2021!

Bonafi takes Bronze in the National Startup Awards 2021!

We are so proud to have won Bronze in the National Startup Awards 2021 in the best Medtech Startup Category.

The recognition goes a long way and it is very rewarding after all the hard work the entire team has put in. Starting a business and building new technology, is most certainly not the easiest path forward. But these types of acknowledgments make all the difference.

A big thank you to everyone in the Bonafi team that has supported us along the way and worked so hard on this.  Also a bit thank you to the National Startup Awards 2021 and all the sponsors that make the Irish Startup Ecosystem glow!

Global Connection Background Through the Whole World, 3d illustration

Digital Transformation continues to be in focus – but how about culture?

Digital Transformation continues to be in focus – but how about culture?

In a pre-COVID 2019 Survey of global pharmaceutical industry professionals, GlobalData reported that less than half of its respondents had a digital strategy in place and 19% had no plans to implement.[1]

Two of the largest barriers hindering digital transformation in pharma, according to industry professionals, was due to organizational and cultural challenges along with technology integration challenges. This is consistent with McKinsey’s findings from 2016. [2] This situation isn’t exclusive to the pharmaceutical industry. Harvard Business Review reported findings from a 2020 survey across multiple sectors that culture was indeed a contributing barrier to digital transformation.[3]

The pandemic, however, has forced us to take a giant step into a digital and virtual world to perform our day-to-day activities and to ensure business continuity. In fact, in a 2021 survey – GlobalData reported that 35% of pharmaceutical industry professionals believe that digital transformation is accelerated in the pharmaceutical industry by more than five years.[4]

Does this mean that our culture has changed? Ask anyone who has had to virtually perform supplier quality audits of companies with paper-based processes; or those who are frustrated by having to trawl through various sources (paper documents, emails, share points etc.) to find due diligence information. They would likely be the first ones to ask for change and feel that a digital transformation couldn’t come soon enough.

However, according to Harvard Business Review’s study – 46% of the surveyed professionals continue to experience culture as a barrier.[5]  This is not surprising given that it can take several years to change an entire organizational culture. As a part of that cultural change, technology must be integrated across all aspects of the business. 89% of the surveyed professionals believe that a successful implementation depends on having a combination of the right culture, the right processes, and the right technology in place.[6]

Peter Drucker coined the phrase “culture eats strategy for breakfast” – clearly that includes digital strategy. Does your pharma organization have the right culture in place to fully embrace digital transformation?

………………………………….

[1] “Digital Disruption is knocking – is healthcare ready?”, GlobalData Presentation CPhI Worldwide 2019, Bonnie Bain, 2019

[2]https://www.mckinsey.com/industries/life-sciences/our-insights/closing-the-digital-gap-in-pharma,

[3] “Accelerating Transformation for a Post-Covid-19 World”, Harvard Business Review Analytic Services, 2021

[4]https://www.globaldata.com/covid-19-accelerated-digital-transformation-timeline-pharmaceutical-industry/

[5] “Accelerating Transformation for a Post-Covid-19 World”, Harvard Business Review Analytic Services, 2021

[6] Ibid;

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Suite B119
The LINC Centre
Blanchardstown Road North
Dublin 15, Ireland

Email: info@bonafi.ie

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EudraGMDP Screen

EudraGMDP: database to be integrated with EMA’s Organisation Management Service (OMS)

EudraGMDP to be integrated with EMA’s Organisation Management Service (OMS)

Regulations 2019/6 and 2021/16, Article 9(h)  |   05 October 2021 

As communicated by EMA:

“The new regulatory framework for veterinary medicines requires several changes to EudraGMDP. The most notable change is the integration of EudraGMDP with EMA’s Organisation Management Service (OMS).

From 28 January 2022, users of EudraGMDP from national competent authorities will no longer introduce organisational data (organisation name and location address details) directly into the relevant fields on the EudraGMDP database. Instead, they will select the relevant organisation name and location address details, including the legally registered address, of the manufacturers/importers/distributors from the Agency’s organisation dictionary (so-called OMS).

It is therefore necessary that all organisations currently regulated through EudraGMDP (which appear on documents within EudraGMDP, including EU and non-EU manufacturers, importers and distributors of human and veterinary medicinal products and active substances) are registered in OMS.”

The development of the database – the Manufacturers and Wholesale Distributors database (MWD) – started on 1 July 2021 and is currently in its test phase.

Status – EudraGMDP to OMS Integration (source: Veterinary Medicinal Products Regulation HIGHLIGHTS, European Medicines Agency, Issue 6, July 2021)

What is the Organisation Management Service (OMS)?

As per EMA the “OMS provides a single source of validated organisation data that can be used as a reference to support EU regulatory activities and business processes.

It stores master data comprising organisation name and location address for organisations such as marketing authorisation holders, sponsors, regulatory authorities and manufacturers. “

OMS has published a Data Quality Standard and integrating EudraGMDP with OMS should ensure more reliable data in the system through the consistent use of organisation master data in EudraGMDP.

What does this mean for access to public data in EudraGMDP?

Our understanding is that “access will continue as before – no changes are foreseen”.  

Webinar

The EMA will organise a webinar on the OMS services for interested manufacturers, importers and distributors on 12 October 2021 at 14:00 – 16:30 CEST. Participants will have the chance to ask questions and seek clarifications on OMS services and activities.

Supplier Qualification Life Cycle

Supplier Qualification: new chapter by U. S. Pharmacopeia

Supplier Qualification – new chapter by U. S. Pharmacopeia

<1083> Supplier Qualification – PF 47(5)   |   03 October 2021

The US Pharmacopeia is proposing a new informational chapter on Supplier Qualification – <1083>. This was previously published as a chapter on good distribution practices and now <1083> is repurposed to focus on a risk-based approach to Supplier Qualifications.

The initiative has its roots in a white paper  “Good Supply Practices for the 21st Century”, published by Xavier Health in 2018 and will discuss the importance of supplier qualification and the application of a quality risk-based approach. 

The chapter outlines examples of supplier types that should be qualified, a six-step process of Supplier Qualification Life Cycle Management along with points to be considered in a risk assessment broken down by risk category.

While the USP general chapters numbered <999> and above are general guidelines rather than being enforceable by law, <1083> contains some good indications on the use of risk-based supplier qualifications. Commenting on <1083> is open until 30 November 2021.

NOTE: To access the document requires an account with USP- which can be created for free on the USP website.

Covid-19 vaccine with ‘fake’ stamp

Council of Europe: Covid-19: what measures to fight against fake vaccines?

Council of Europe: Covid-19: what measures to fight against fake vaccines?

Strasbourg   |   27/04/2021

“Amid the rise in counterfeiting and other illegal activities related to the Covid-19 pandemic, the Council of Europe is issuing new recommendations to governments based on its Convention on the counterfeiting of medical products and similar crimes involving threats to public health (MEDICRIME Convention).

As regulators around the world approve more vaccines for sale, reports of seizures of counterfeit vaccines continue to rise.

In an opinion published today, the MEDICRIME Committee sets out 13 measures to prevent and combat the presence of counterfeit vaccines on the market, including vaccines that misrepresent their identity and/or source, as well as the diversion of legally produced vaccines from the legal supply chain.

The Committee proposes preventive measures in co-operation with the relevant sectors to strengthen the supply chain, ensure the authenticity of vaccines, and improve arrangements for the disposal of Covid-19 vaccine waste.

The Committee also emphasises the importance of training relevant government officials (customs officers, police and judges) and raising public awareness.

Background

The only international treaty of its kind, the 2011 Convention on the counterfeiting of medical products and similar crimes involving threats to public health (MEDICRIME Convention) has been ratified by 18 countries and signed by 15 others in Europe and beyond.

The Convention provides a framework for national and international co-operation between the competent health, police and customs authorities at both national and international level, measures for crime prevention by also involving the private sector, and the effective prosecution of crime and the protection of victims and witnesses.

In 2020, the MEDICRIME Committee published an opinion on the application of the Convention in the context of Covid-19.

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Suite B119
The LINC Centre
Blanchardstown Road North
Dublin 15, Ireland

Email: info@bonafi.ie

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