Beschreibung
For our client, a pharmaceutical company in Basel, we are looking for a motivated and ambitious:
Senior Quality Assurance Manager
Background:
The Quality Assurance 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 (ie 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 life cycle 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.
Must Haves:
- 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
Nice to Haves:
+++ German
Start date: latest 15.01.2018
End date: 30.06.2018 (+ possible extension)
Location: Basel
Are you interested to work in this challenging position? Alessia Biassoli, Talent Resourcer, is looking forward to receiving your complete profile. Please send an e-mail (see below)