Operations QA Specialist

1. The Operations QA is a role within the German QA organization responsible for ensuring effective quality oversight of day-to-day operations at the Wuppertal site (MFG19), including QC laboratory activities, material release, inspection readiness, and client-related quality activities. The role ensures that these activities are conducted in compliance with GMP requirements, applicable regulations, and internal procedures and processes.

1. At least 3 years of relevant working experience in the pharmaceutical industry

2. A Bachelor’s degree in a technical discipline would be an advantage

3. Strong oral and writing English (Chinese and German is a plus)

4. Solid understanding of GMP and European regulations (German drug law is a plus)

5. Results oriented and ability to deliver under pressure in a fast paced environment

6. Think individually with a strong sense of service, decisiveness and responsibility. Good knowledge of Microsoft Office – Powerpoint, Word, Excel

1. Good organizational skills

2. Good interpersonal communication skills

3. Excellent oral & written communication skills (English; German is preferable)

• Review and approve specifications, sampling procedures, and test procedures for raw materials, excipients, intermediates, drug substances, and drug products.
• Ensure that environmental monitoring and environmental control activities, including cleanrooms, water systems, and other utilities, are performed in accordance with established procedures and GMP requirements.
• Review and approve stability protocols and reports for intermediates and drug substances.
• Review and approve batch analytical records to ensure completeness, accuracy, and compliance with applicable procedures and GMP requirements.
• Provide quality oversight of QC testing activities to ensure that all testing and laboratory operations are performed in accordance with approved SOPs and applicable GMP requirements.
• Review and approve QC-related quality documents and records, including Certificates of Analysis (CoAs), Change Controls, Deviations, Laboratory Investigations, Quality Risk Assessments (QRAs/QRM), quality memos, and other relevant quality documentation.
• Oversee the testing record review and material release processes, ensuring timely and compliant release of materials.
• Coordinate the planning, preparation, execution, and follow-up of regulatory inspections, client audits, and corporate audits conducted at German manufacturing sites and Quality Control locations.
• Lead or support the preparation, revision, review, approval, and implementation of relevant SOPs, including the provision of training to personnel as required.
• Coordinate and participate in client meetings to discuss, follow up, and resolve quality-related topics and commitments.
• Perform other quality-related duties and responsibilities as assigned by the direct supervisor.