Quality Assurance Manager Drug Product (m/f/d)

Location: Basel

Contract duration: 12 months

Responsibilities:

• Review of Drug Product Batch Records, in cooperation with the relevant departments.
• Implementation of the IMP Drug Product release.
• Review and release of documents such as: specifications, risk assessments, deviation reports and change control records.
• Review and approval of cleaning protocols and reports.
• Support of the supervised departments with GMP-relevant issues.
• Conducting self-inspections.

Requirements:

• Completed scientific studies, at least at Master's level.
• Fluent written and spoken German and English skills
• At least 10 years of professional experience in the pharmaceutical industry, of which at least 5 years in quality assurance.
• Knowledge of cGMP and quality requirements for clinical development phases.
• Proven success in inspections by health authorities and internal GMP audits.
• Good IT skills (MS Office) - especially the handling of SAP, as well as other quality management systems (e.g. Veeva Vault).