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

Java Software Engineer – Ireland

Careers at Bonafi

Java Software Engineer

Bulgaria – Full time – Software development – Experienced

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

Back to Bonafi – Career at Bonafi

Apply for this position

Quality Assurance Associate – Ireland

Careers at Bonafi

Quality Assurance Associate - Ireland

Bulgaria – Full time – Quality Assurance Associate- Experienced

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

Back to Bonafi – Career at Bonafi

Apply for this position

QA Tester

Careers at Bonafi

QA Tester

Bulgaria – Full time – QA Testing – Experienced

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

Back to Bonafi – Career at Bonafi

Apply for this position

Software Developer

Careers at Bonafi

Software Developer

Bulgaria – Full time – Software development – Experienced

Introduction

Overview of the job’s responsibilities:

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

Back to Bonafi – Career at Bonafi

Apply for this position

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!

Share our News!

Global Connection Background Through the Whole World, 3d illustration

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;

Share our News!

NEWS

FIND US

Bonafi Limited

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

Email: info@bonafi.ie

GET IN TOUCH

NAVIGATE

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: 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.

Link to the document here

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

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.“

Link to the article here

NEWS

FIND US

Bonafi Limited

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

Email: info@bonafi.ie

GET IN TOUCH

NAVIGATE

Digital strategy in pharma: GAMP Francophone position paper on CSA

Digital strategy in pharma:
GAMP Francophone position paper on CSA

GAMP Francophone Position paper on CSA – Computer Software Assurance

In light of the COVID-19 pandemic, too low levels of adopting a digital strategy in the pharmaceutical industry and the prevalence of paper-based processes in the validation of applications and processes , GAMP Francophone, has published a position paper on US-FDA’s initiative on CSA – Computer Software Assurance. The CSA is a prioritized guidance document, intended to be published in FY2021by the FDA. The new guidance is intended to shift the focus of the document-oriented computer validation towards a risk-based, critical thinking approach.

The position paper observes that the practices in the healthcare industry “show a certain difficulty, or even inability, to take advantage of technological developments and alternative project management approaches”

The paper stresses the importance of not immobilizing the technical and digital evolution while waiting for FDA’s new guidance document on CSA– but meticulously plan for the anticipated progress and take the opportunity to invest in the understanding of new technologies. It also underlines that the current European regulatory framework “through its systematic consideration of quality risk management”, currently do provide generous amplitude for implementing new and innovative approaches and that GAMP5 in a similar manner encourages creativity and efficiency in their industry practices.

As a company developing digitized compliance solutions to the pharmaceutical industry which will be validated, we are certainly looking forward to the published guidelines.