Technical responsibility for the release of pharmaceutical products in the solids sector (drug products as well as primary and secondary packaging)
Independent creation, review, and strategic development of batch records in close coordination with customers and internal subject matter experts
Lead responsibility for handling complex deviations, change requests (change controls), complaints, and responsibility for preparing, evaluating, and presenting PQRs/APRs
Ensuring and continuously optimizing GMP-compliant production processes in close cross-departmental collaboration with production, engineering, and other interfaces
Planning, management, and technical supervision of qualification and validation activities
Creation, approval, and continuous development of SOPs and guidelines
Active involvement in the further development, digitization, and automation of processes and software-supported quality systems, including Computer System Validation (CSV)
Technical responsibility and (partial) project management in digitization and AI projects in the QA environment
Your profile
Completed degree in pharmacy, natural sciences, or a comparable qualification
Several years (typically 5+) of professional experience in quality management at a pharmaceutical company
Very good and practical knowledge of the regulatory environment (GMP, GCP) as well as experience in dealing with regulatory audits and inspections
Extensive expertise in digital transformation, computer system validation (CSV), and the application of AI in regulated environments
Very good knowledge of software-based quality systems (e.g., eQMS), MS Office; SAP knowledge is an advantage
Excellent communication and presentation skills in German and English
Your advantage:
A friendly atmosphere and an uncomplicated working environment with a positive team spirit
Joint further development in a promising market
Further training opportunities
Attractive benefits
Our customer
Is a successful, innovative Swiss pharmaceutical company based in the Baselland region.
