Compliance Manager in Quality Assurance
vor 2 Wochen
NextPharma: A Leading Contract Manufacturer in the Pharmaceutical Industry
We are a top European contract manufacturer specializing in the pharmaceutical, biotech, and healthcare industries. Our focus is on progression, and our energetic environment fuels our growth.
About the Role
We are currently seeking a highly skilled Compliance Manager in Quality Control to strengthen our team in Berlin. This is an exciting opportunity to join a dynamic organization and contribute to our success.
Key Responsibilities
- Provide organizational support to the Quality Control management team
- Optimize workflows in Quality Control to ensure efficiency and effectiveness
- Ensure analytical compliance in Quality Control regarding pharmacopoeial monographs, test specifications, test protocols, specifications, and approvals
- Ensure conformity of the internal quality system in the QC department with current GMP guidelines
- Develop, revise, update, or review SOPs, test plans, and test instructions (for QC area, focusing on GMP compliance)
- Participate in handling (including reporting) of deviations, OOS/OOT results
- Take part in implementing measures within change control procedures and CAPA actions in the QC area
Additional Tasks
- Review of analytical raw data and audit trails
- Planning and participation in the qualification of equipment for the Quality Control area, and preparation or review of relevant documentation
- Develop or review verification/validation plans
What We Offer
- Customized On-Boarding
- Remote work, flexible working hours, and 30 vacation days
- Company pension scheme
- Employee events and corporate sports activities
- Training at the internal NextAcademy
- Internal advancements and cross-site career opportunities
- Employee discounts
Requirements
- Degree in natural sciences (Pharmacy, Chemistry, Biology, Biotechnology, or similar)
- Several years of experience in pharmaceutical Quality Control and/or Quality Assurance
- Knowledge of relevant regulations like the EU GMP guidelines
- Willingness to learn, open-minded personality, meticulous work style, high level of responsibility and dedication
- Proficient in Microsoft Office applications
- Excellent German and very good English language skills (written and spoken)
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