At a Glance
- Tasks: Manage and archive essential documentation for GMP manufacturing processes.
- Company: Join a leading organisation committed to quality and compliance in the pharmaceutical industry.
- Benefits: Part-time role with flexible hours, competitive pay, and valuable experience.
- Other info: Opportunity for professional growth in a dynamic and supportive environment.
- Why this job: Be a key player in ensuring data integrity and compliance while developing your skills.
- Qualifications: A Levels in science and knowledge of GMP and documentation management preferred.
The predicted salary is between 30000 - 40000 € per year.
The Archivist is responsible for managing all aspects of local documentation archiving across on-site, external and electronic archives. The incumbent ensures documentation, records and information related to GMP manufacturing processes are accurately and securely maintained, accessible, and that data integrity is protected throughout record lifecycles. Documentation is correctly classified, indexed and retained compliantly according to required retention periods, and compliance with EU GMP, data integrity, biosafety, HSE, BI Global/Local SOPs and EU Directive 2001/82/EC is maintained. This is a Fixed-Term & Part-time role (3 days a week) until December 2027.
Tasks & Responsibilities
- Oversight of Local Archive
- Ownership & management of local procedures related to the archive.
- Regular archiving of GxP documents.
- Manage entry/retrieval of documents.
- Ensure access control, safekeeping and key control.
- Identify key archiving attributes and support record retention assignment.
- Orchestrate the document reconciliation process.
- Ensure orderly storage of records.
- Control/document movement of records.
- Conduct periodic spot checks of retrieval time.
- Maintain stock of archiving consumables.
- Destroy records after the retention period.
- Retrieve documents timely for audits/inspections.
- Continuously improve the archiving process.
- Train individuals and users in true copy generation and archiving.
- Oversight of External Archive
- Manage storage/retrieval of documents to an off-site facility.
- Manage annual purchase orders.
- Oversee destruction of records after the retention period.
- Act as SME for external archive audits (e-DMS Archivist).
- Move obsolete/retired documents to the archive folder in VQD and delete them at the end of the retention period.
- Audits & Inspections
- Ensure audit/inspection readiness.
- Organise and prepare documentation for audits/inspections.
- Participate and support during regulatory inspections, global quality audits and internal audits.
Requirements
- Knowledge of EU GMP, documentation management, archiving & data integrity within GMP environments.
- Education: Minimum three A Levels (or equivalent) at grades A–C including one scientific discipline. Archiving & records management qualification is beneficial.
Required Skills & Competencies
- Knowledge and experience of GMP, data integrity, documentation management.
- Ability to assess and understand large volumes of records.
- Good IT skills, including databases.
- Excellent organisation and prioritisation.
- Strong attention to detail and accuracy.
- Strong commitment to customer service.
- Clear, professional communication (verbal & written).
- Ability to form constructive relationships at all levels.
- Ability to work independently and in teams.
- Ability to deliver training.
A successful candidate may be asked to undergo a Basic DBS Security Check.
GxP Records Archivist employer: Boehringer Ingelheim
As a GxP Records Archivist, you will join a dynamic team dedicated to maintaining the highest standards of documentation management within a supportive and collaborative work environment. Our company prioritises employee growth through continuous training opportunities and fosters a culture of integrity and excellence, ensuring that your contributions are valued and impactful. Located in a vibrant area, we offer flexible working arrangements that promote a healthy work-life balance, making us an exceptional employer for those seeking meaningful and rewarding employment.
StudySmarter Expert Advice🤫
We think this is how you could land GxP Records Archivist
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Tailor your answers to show how your skills align with their needs, especially around GxP and data integrity. We want to see that you’re not just a fit on paper but also in practice!
✨Tip Number 3
Practice makes perfect! Do mock interviews with friends or use online resources to get comfortable with common questions. The more you rehearse, the more confident you'll feel when it’s time to shine.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who are proactive about their job search!
We think you need these skills to ace GxP Records Archivist
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the GxP Records Archivist role. Highlight your experience with documentation management and any relevant qualifications. We want to see how your skills align with our needs!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about archiving and how you can contribute to maintaining data integrity. Keep it professional but let your personality show through.
Showcase Your Attention to Detail:In this role, attention to detail is key. Use specific examples in your application that demonstrate your ability to manage records accurately and securely. We love candidates who can prove they’ve got what it takes!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy to do!
How to prepare for a job interview at Boehringer Ingelheim
✨Know Your GxP Inside Out
Make sure you brush up on your knowledge of Good Practice (GxP) guidelines, especially EU GMP. Familiarise yourself with the key principles of documentation management and data integrity, as these will likely come up during the interview.
✨Showcase Your Organisational Skills
Prepare examples that demonstrate your ability to manage large volumes of records and maintain accurate documentation. Think about specific situations where you've successfully organised or improved an archiving process, as this will highlight your attention to detail.
✨Be Ready for Scenario Questions
Expect questions that ask how you would handle specific situations, like preparing for an audit or managing document retrieval. Practise articulating your thought process clearly, as this will show your problem-solving skills and ability to work under pressure.
✨Communicate Clearly and Confidently
Since clear communication is key in this role, practise explaining complex concepts in simple terms. Be prepared to discuss how you would train others in archiving processes, as this will demonstrate your ability to form constructive relationships and deliver training effectively.
