Operations QA Specialist

WuXi Biologics; Wuppertal; On-site; EUR 65,000 - 90,000; Full time

Job summary

WuXi Biologics seeks an Operations QA professional for its Wuppertal site (MFG19) to oversee day-to-day quality operations in GMP-compliant laboratories and manufacturing facilities. You will review specifications, ensure environmental monitoring, and support regulatory inspections and client audits.

The role requires 3+ years in pharma, a technical bachelor’s degree is preferred, and strong English communication.

Qualifications

• At least 3 years of relevant working experience in the pharmaceutical industry.
• Bachelor’s degree in a technical discipline would be an advantage.
• Strong oral and writing English; Chinese and German is a plus.
• Solid understanding of GMP and European regulations; German drug law is a plus.
• Results oriented with ability to deliver under pressure.

Responsibilities

• Review and approve specifications, sampling procedures, and test procedures for materials and products.
• Ensure environmental monitoring and control activities are performed per procedures and GMP requirements.
• Review and approve stability protocols and reports for intermediates and drug substances.
• Review and approve batch analytical records for completeness and GMP compliance.
• Provide quality oversight of QC testing activities and ensure SOPs and GMP requirements are followed.
• Review and approve QC-related quality documents and records (CoAs, Deviations, QRAs, and quality memos).
• Oversee testing record review and material release processes for timely, compliant release.
• Coordinate inspections and client/corporate audits at German manufacturing sites and QC locations.
• Lead or support SOP development and training for personnel as required.
• Coordinate client meetings to discuss quality topics and commitments.

Skills

GMP knowledge

Quality oversight

English proficiency

Interpersonal skills

MS Office

Decisive

Organizational skills

Education

Bachelor’s degree in technical discipline

Tools

PowerPoint

Word

Excel

Job description

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.