Quality Control Specialist (m/w/d)

Tasks :

• Review and approve Master batch records and ensure conformance to all applicable policies/procedure and compliance with all governing regulations.

• Manage routine and complex deviations

• Support process and analytical change requests.

• Assist the maintenance of retention samples, ship reagents and samples to support licensure and foreign registration; responsible for shipment under quarantine.

• Support routine process validation; review and approve validation reports/tech transfer

• Prepare pre-PAI assessments; support document requests for regulatory filings and post approval changes.

• Regular site visits to build relationships and monitor efforts to improve the external manufacturer’s quality and reliability through ongoing oversight and formal communication programs and forums.

• Previous experience in the pharmaceutical industry with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control including global GMP Quality Systems

Qualification:

• Solves complex problems; takes a new perspective using existing solutions.

• Works independently, receives minimal guidance.

• Acts as a resource for colleagues with less experience within own discipline; can provide minimal guidance on issue resolution and act as SME.

• May act as a team or project lead and lead work of others as required; promotes teamwork and open discussion of issues, coaches and guides others.

• Explains difficult issues and works to build alignment around a complex situation.

• Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills.

• Strong knowledge of External Manufacturing management, supply chain, and operations.

• Fluent in English, German language skills are of advantage

• Nice to have:

• Direct experience with managing external partners.

• Experience with manufacturing operations and/or analytical expertise associated with

• biologics and/or vaccines.

• Previous experience with regulatory communications such as Biologics License Applications

• (BLAs), New Drug Applications (NDAs)

• Degree in Science, Engineering or any relevant technical discipline (BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or equivalent preferred).

• Previous experience in the pharmaceutical industry with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control including global GMP Quality Systems and regulatory requirements preferred

Requirements:

Start : 01.09.2025