Operations QA Specialist

Teil II Primäres Ziel der Stelle / Part II Primary Job Objective

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.

Teil III Mindestanforderungen an die Stelle / Part III Minimum Requirements

Bildungshintergrund und Erfahrung / Education Background and Experience

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

2. A Bachelors 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

Besondere Kenntnisse / Special Knowledge

1. Good organizational skills

2. Good interpersonal communication skills

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

Teil IV Berufliche Verantwortung / Part IV Job Responsibilities

1. Review and approve specifications sampling procedures and test procedures for raw materials excipients intermediates drug substances and drug products.
2. 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.
3. Review and approve stability protocols and reports for intermediates and drug substances.
4. Review and approve batch analytical records to ensure completeness accuracy and compliance with applicable procedures and GMP requirements.
5. 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.
6. 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.
7. Oversee the testing record review and material release processes ensuring timely and compliant release of materials.
8. 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.
9. Lead or support the preparation revision review approval and implementation of relevant SOPs including the provision of training to personnel as required.
10. Coordinate and participate in client meetings to discuss follow up and resolve quality-related topics and commitments.
11. Perform other quality-related duties and responsibilities as assigned by the direct supervisor.