Quality Assurance Specialist – 12 months Contract , Basel
We are looking for a quality specialist to support management of QA/QC processes and procedures, product responsibility, validation and qualification.
• Provides scientific and technical expertise on QA/QC procedures within the quality department and other organizations
• Maintains and adheres to cGMP, SOPs, Rolling Review, CAPA
• Prepares, participates in and conducts authority inspections and audits
• Ensure uniform GMP standards through regular exchange with central QA function
• Initiate revision, validation and improvement of GMP documents e.g. testing monographs, SOP's, qualification and validation documents
• Provide input to health authority requests
• Manage investigations regarding product quality (e.g. OOS/OOE, deviations, customer complaints)
• Procures validation support; supports launches
• Local and global project participation or lead
• Maintains state-of-the-art knowledge of Health Authority requirements, trends, technologies, processes and systems.
Requirements: • Implementation of the quality process improvements with impact on time, quality and costs
• provide expertise and support the technical operations and quality department • Keep timelines (e.g. availability of documentation, qualification, validation, batch release, investigations,…)
• experience with authority inspections and audits
• Successful implementation of cross-functional projects.
University or academic degree in Chemistry, Biology, Pharmacy or equivalent
Languages: German and English
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.