Description
We are looking for a
Senior Quality Assurance Manager (QA & Validation) (m/f)
Reference: -en
Start: ASAP
Duration: 6 MM
Place: in Basel-City
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Perform quality assurance tasks regarding validation of global computerized systems according to the GMP inventory and regarding projects (i.e. PT strategic projects and smaller projects)
- Align quality assurance tasks across the organization within the department as well as with other global or local functions
- Provide guidance for local quality departments
- Assure compliance of systems according to the GMP inventory by providing templates, support in creation of CSV documentation, review and approval of SOPs
- Support Quality Assurance tasks regarding validation of computerized systems, including review and approval of validation lifecycle documents, review and approval of validation reports and release systems according to CSV, approval of change requests and owning discrepancies
- Support interpretation of the Roche policy and directives as well as external guidelines
Your qualifications
- B.S. or B.A. degree, preferably in Life Science
- In-depth relevant experience in the pharmaceutical or biopharmaceutical industry with sound knowledge of cGMPs or equivalent regulations
- Demonstrated expertise with computer system validation and risk management, change control, and discrepancy/CAPA management (most important requirement)
- Experience in working in validated or controlled environments and ability to propose pragmatic quality approaches while maintaining full compliance to regulations and standard
- Knowledge of manufacturing, cGMP's and compliance
- Excellent collaborator with proven ability to work well with others in a proactive, positive and constructive manner
- Strong self-motivator, able to manage multiple priorities
- Demonstrated influencing and interpersonal skills with strong written and verbal communication skills; ability to communicate effectively with all levels of the organization
- Strong German skills
Skills:
- Qualification/validation specialist