For our Swiss customer located in Basel we are currently looking for (m/f) a Senior Quality Assurance Manager (QA & Validation)
- Type of placement: 6 months, external contract with possible long term extension
- Company: major Pharma company in Basel area
- Salary: level 2-3, please ask us for the exact rate range
(monthly all in salary levels in CHF, level1= 5-10k , level2=10-15k, level3= >15k)
We need a QA manager to perform tasks around Computer Systems Validation of global computerized systems. The position is located in Basel but the contractor will be working in global teams with other members being located in San Francisco.
Tasks & Responsibilities
- 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 Policy and Directives as well as external guidelines.
- Start date: 02.01.2018
- Latest start date: 15.01.2018 (as soon as possible in the new year)
- End date: 30.06.2018
- Extension: An extension is planned, but needs to be approved.
- Work location: Basel
- Workload: 100%
- Remote/Home Office: Possible 1 day per week (prior approval needed).
- Travelling: Not required
- Department: PTQS - Global Quality Computer System Validation (non-IT)
- B.S. or B.A. degree, preferably in Life Science
- 8 to 10 years of relevant experience in the pharmaceutical or biopharmaceutical industry with sound knowledge of cGMPs or equivalent regulations as well as 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
- High quality orientation with attention to detail; drives for excellence and positive business outcomes
- Excellent collaborator with proven ability to work well with others in a proactive, positive and constructive manner
- Strong self-motivator who can 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