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Quality Assurance Manager
vor 2 Monaten
We are seeking a highly skilled Quality Assurance Manager to join our team at PAION Pharma GmbH. As a key member of our quality team, you will be responsible for ensuring that our contract manufacturers comply with EU-GMPs, international guidelines, and internal quality standards.
Key Responsibilities- Quality System Management: Ensure the continuous improvement of assigned quality systems as system owner, with a focus on cost and safety awareness.
- Deviation and CAPA Management: Handle deviations, CAPAs, laboratory investigations, customer complaints, and GDP incidents in a timely and effective manner.
- Audit and Compliance: Perform GLP and GMP audits at contractor sites, prepare audit reports with CAPAs, and follow up to ensure continual improvement in quality.
- Internal Audit and Risk Assessment: Conduct internal audits, risk assessments, and root cause analyses to improve our quality management system.
- Technology Transfer and Method Validation: Support QC teams in transfer of technology projects, review and approve QC testing methods, and prepare and review validation and method transfer protocols and reports.
- Product Change Coordination: Evaluate and coordinate product changes according to PAION Change Control procedures to ensure product/procedural compliance with registration, applicable regulations, and business expectations.
- Supplier Evaluation and Management: Manage the supplier evaluation system as system owner.
- Batch Record Review and Certification: Review batch records, provide trending of results to support certification of batches, and review raw data and finished product testing documents.
- Education: MSc degree in life science, preferably pharmacy, biology, or chemistry.
- Experience: 5 years or more experience in the pharma industry GLP, GMP, and GDP environment.
- Skills: Basic knowledge in Regulatory Affairs and fluency in German and English.
PAION Pharma GmbH is a specialty pharmaceutical company in the field of anaesthesia and critical care, specializing in innovative active pharmaceutical ingredients for use in outpatients and hospitals. We are part of the Humanwell Healthcare Group.
