Beschreibung
Senior Quality Assurance Manager – Business Quality Assurance Management – CSV – Computer System Validation – GMP – SAP – HP ALM – Pharmaceutical – English – Basel – Switzerland
NextLink is having an existing position as a Senior Business Quality Assurance Manager for global projects in Basel, Switzerland.
General information
Start date: preferred on-boarding in Dec / Real Start Date: 06.01.2020
Latest start date: 06.01.2020
End date: 31.03.2020
Extension: Extension planned, has to be approved
Workload: 100%
Work location: Basel
Remote: max. 50%
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 Roche Policy and Directives as well as external guidelines
Must Haves
• 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
• Proven experience working with SAP / ERP / Serialization Systems
• Experience working with HP ALM
• 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
• Fluent in English
For a chance to work as a Senior Business Quality Assurance Manager please call me or send me your CV as soon as possible!
Leila Benabdallah
IT sourcing specialist
Phone: