Quality Assurance Specialist
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QA Specialist – QA Operations & Digital Manufacturing
We are looking for two QA profiles within the same QA Operations environment for a pharmaceutical company: one with a stronger focus on digitalization, electronic batch records (eBR) and MES, and one with a stronger focus on day-to-day QA Operations, batch record review and production support. The profile below provides a combined summary of both positions, with the key differences reflected in the responsibilities and requirements.
Your Responsibilities
- Perform quality reviews of electronic and paper-based batch records, logbooks and other operational documentation.
- Review and approve Electronic Master Batch Records (eMBRs) within a MES environment, preferably PAS-X.
- Support the transition from paper-based to electronic batch records and other manufacturing digitalization initiatives.
- Prepare, review and maintain Quality documentation, including project documentation, quality plans, SOPs, forms and risk assessments.
- Contribute to Deviation Prevention (DPP) and Human Error Prevention (HEP) initiatives.
- Ensure compliance with cGMP, SOPs, global standards, applicable regulations and product registrations for clinical and commercial manufacturing.
- Provide quality oversight within manufacturing operations, including operational documentation and alarm management.
- Collaborate with various departments across Quality, Manufacturing and project teams.
- Identify quality and compliance issues and escalate them appropriately when required.
- Contribute to continuous improvement of quality and manufacturing processes.
What We Are Looking For
- A Master’s degree in a scientific discipline, or equivalent experience.
- Strong knowledge of and experience with cGMP in a regulated manufacturing environment.
- Experience in Quality Assurance and Quality processes.
- Experience with batch record review.
- Experience with electronic batch records and/or MES systems; experience with PAS-X is a plus.
- Knowledge of data integrity within a GMP environment.
- Experience with manufacturing and/or digitalization projects is a plus.
- Experience with clinical manufacturing and related regulations is a plus.
- Excellent attention to detail and a high level of accuracy.
- Independent and proactive working style.
- Strong communication and teamwork skills.
- Strong written communication skills in English.
What We Offer
You will join a professional, internationally oriented manufacturing environment where quality, compliance and digitalization are key priorities. The role offers the opportunity to contribute both to day-to-day QA Operations and to important digitalization initiatives within manufacturing.
Interested? Please get in touch via this page
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