Be the guardian of quality on the shopfloor, ensuring every batch meets world‑class GMP standards.
Proclinical is seeking a Quality Assurance Specialist Shopfloor to join a dynamic team within an international Contract Development and Manufacturing Organization (CDMO). In this role, you will play a key part in ensuring compliance with Good Manufacturing Practices (GMP) across manufacturing, warehousing, and quality control operations. This position offers the opportunity to contribute to the production of oncology-related products while driving continuous improvement in quality processes.
Responsibilities:
- Provide daily GMP oversight for manufacturing, warehousing, QC, and MSAT operations, with a focus on shopfloor activities.
- Conduct routine quality monitoring of production steps, logbooks, batch records, storage, and testing activities.
- Prepare batch documentation packages and perform real-time batch record reviews on the shop floor.
- Inspect and release cleanrooms for GMP manufacturing.
- Perform Acceptable Quality Level (AQL) assessments following visual inspection activities.
- Oversee GMP activities for drug product manufacturing, including formulation, aseptic filling, lyophilization, visual inspection, and packaging.
- Manage abnormal or rejected materials physically and in SAP, including blocking/unblocking and maintaining material master data.
- Support quality events such as Change Controls, Deviations, and CAPAs.
- Review and revise SOPs, QRAs, and MBRs to drive continuous improvement.
- Perform electronic data reviews to ensure data integrity and compliance.
- Support self-inspections, client audits, and authority inspections as a Subject Matter Expert (SME) or back-office support.
- Take on additional responsibilities as assigned by the supervisor.
Key Skills and Requirements:
- Degree in Chemistry, Biochemistry, Microbiology, Molecular Biology, Biological Engineering, or a related field.
- Proven experience in GMP within QA, QC, MSAT, or Manufacturing.
- Familiarity with biological product development or pharmaceutical manufacturing.
- Strong knowledge of GMP and regulatory standards (EMA, FDA, ICH, WHO).
- Professional working proficiency in both German and English.
- Excellent interpersonal, communication, and organizational skills.
- Proactive mindset with the ability to influence and drive improvements.
- Willingness to work in shift-based schedules when required.
- Ability to pass a visual inspection qualification.
- Proficiency with Microsoft Office and common digital tools.
If you are having difficulty in applying or if you have any questions, please contact Antoine Mortiaux at a.mortaiux@proclinical.com.
Apply Now:
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Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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