Senior QA Consultant

Walker Cole International is supporting an exciting opportunity within a leading pharmaceutical manufacturing project in Germany in the appointment of two Senior QA Consultants (Labour Leasing).

The positions will focus on manufacturing quality oversight, ensuring that the Contract Manufacturing Organisation (CMO) operates in compliance with GMP regulations and adheres to the client’s Quality Agreement requirements.

Key responsibilities:

• Provide QA oversight of manufacturing activities within the CMO environment.
• Support deviation management, including investigation and timely closure.
• Lead and support sterility assurance activities, with a strong focus on aseptic processes.
• Oversee aseptic manufacturing environments to ensure compliance with GMP standards.
• Conduct Gemba walks, including material receipt and production areas.
• Support and review visual inspection activities.
• Ensure data integrity standards are maintained across all operations.
• Drive and monitor overall GMP compliance across the site.

Required experience and skills:

• Significant experience in GMP-regulated pharmaceutical manufacturing environments.
• Strong expertise in sterility assurance and aseptic processing (essential).
• Proven track record in QA oversight within a CMO setting.
• In-depth knowledge of deviation management, data integrity, and GMP compliance.
• Strong communication and stakeholder management skills.
• Fluency in German is advantageous but not essential.
• Minimum of 8 years’ relevant experience in a senior QA capacity.

Working pattern:
Full-time Onsite (100%)

Employment type:
Contract (Labour Leasing only)

Location:
North Rhine-Westphalia, Germany

Duration:
May to end of October

Keywords:
QA Consultant | GMP | Sterility Assurance | Aseptic Manufacturing | CMO | Quality Oversight | Deviations | Data Integrity | Visual Inspection | Gemba | Pharmaceutical

ID:
103108