At a Glance
- Tasks: Manage and archive essential documentation for GMP manufacturing processes.
- Company: Join a leading company 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 and development until December 2027.
- Why this job: Be a key player in ensuring data integrity and compliance in a dynamic environment.
- Qualifications: A Levels in science and knowledge of GMP and archiving processes required.
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. Ensures documentation is correctly classified, indexed and retained compliantly according to required retention periods, and ensures compliance with EU GMP, data integrity, Biosafety, HSE, BI Global/Local SOPs and EU Directive 2001/82/EC. 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.
- Manages entry/retrieval of documents.
- Ensures access control, safekeeping and key control.
- Identifying key archiving attributes & supporting record retention assignment.
- Orchestration of document reconciliation process.
- Ensures orderly storage of records.
- Controls/documentation of movement of records.
- Periodic spot checks of retrieval time.
- Maintaining stock of archiving consumables.
- Destruction of records after retention period.
- Timely retrieval of documents for Audits/Inspections.
- Continuous improvement of Archiving process.
- Training individuals & users in true copy generation and archiving.
- Oversight of External Archive
- Manages storage/retrieval of documents to off-site facility.
- Management of annual Purchase Orders.
- Oversight of destruction of records after retention period.
- Acts as SME for external archive audits e-DMS Archivist.
- Moves obsolete/retired documents to archive folder in VQD and deletes at end of retention period.
- Audits & Inspections
- Ensures Audit/Inspection Readiness.
- Organising and preparing documentation for audits/inspections.
- Participation 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 beneficial.
- Knowledge & experience of GMP, data integrity, documentation management.
- Ability to assess/understand large volumes of records.
- Good IT skills incl. databases.
- Excellent organisation & prioritisation.
- Strong attention to detail & 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 GmbH
As a GxP Records Archivist, you will thrive in a dynamic work environment that prioritises compliance and data integrity while fostering a culture of continuous improvement. Our company offers flexible part-time hours, allowing for a balanced work-life integration, alongside opportunities for professional development and training in archiving best practices. Join us in a location that values meticulous organisation and teamwork, ensuring that your contributions are recognised and impactful within the realm of GMP documentation management.
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 refer you directly.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Tailor your responses to show how your skills align with their needs, especially around GxP and data integrity. We want to see that you’re genuinely interested!
✨Tip Number 3
Practice makes perfect! Do mock interviews with friends or use online resources to get comfortable with common questions. The more you practice, 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 take the initiative to engage directly with us.
We think you need these skills to ace GxP Records Archivist
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that match the GxP Records Archivist role. Highlight your knowledge of EU GMP and documentation management, as these are key to impressing us.
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 your background makes you a perfect fit for our team. Keep it professional but let your personality show!
Showcase Your Attention to Detail:In this role, accuracy is everything. When submitting your application, double-check for any typos or errors. A polished application shows us you care about quality and precision.
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!
How to prepare for a job interview at Boehringer Ingelheim GmbH
✨Know Your GxP Inside Out
Make sure you brush up on your knowledge of Good Practice (GxP) regulations and documentation management. Familiarise yourself with EU GMP guidelines and be ready to discuss how they apply to archiving processes. This will show that you’re not just a candidate, but someone who understands the industry.
✨Showcase Your Organisational Skills
Since this role requires excellent organisation and prioritisation, prepare examples from your past experiences where you successfully managed large volumes of records or improved archiving processes. Be specific about the tools and methods you used to keep everything in order.
✨Prepare for Audits and Inspections
Expect questions about your experience with audits and inspections. Think of instances where you’ve prepared documentation for such events or participated in them. Highlight your ability to ensure audit readiness and how you’ve contributed to maintaining compliance in previous roles.
✨Communicate Clearly and Confidently
As communication is key in this role, practice articulating your thoughts clearly. Prepare to discuss how you’ve trained others in archiving processes or communicated complex information effectively. This will demonstrate your ability to form constructive relationships and work well in teams.
