Senior Quality Assurance Manager
Vor 5 Tagen
Job Summary:
The Senior Quality Assurance Manager will be responsible for ensuring that all manufacturing processes and cleaning processes for manufacturing equipment throughout their lifecycle are performed and validated in compliance with cGMP requirements and internal/external quality standards.
Key Responsibilities:
- Develop and implement Process Validation strategies in conjunction with MSAT.
- Coordinate Quality and Compliance objectives during the different project phases with regard to the Process and Cleaning Validation activities.
- Review and approval of Process and Cleaning Validation related documents (plans, protocols, reports).
- Support and approve Quality Risk Analysis related to manufacturing processes and equipment cleaning (e.g. FMEA).
- Ensure accuracy of data detailed within process and cleaning validation reports.
Requirements:
- BSc, MSc, or PhD in Biotechnology, Pharmacy, Microbiology, Chemistry, Engineering, or related field.
- 5+ years experience in the area of biopharmaceutical manufacturing, preferably in a QA/qualification/validation/MSAT function as well as a strong background in cGMPs.
- Good communication skills and interaction with all kind of interfaces within the organization, with customer representatives, and with regulatory agencies (Swissmedic, FDA etc.).
About Lonza:
Lonza is a global leader in life sciences operating across three continents. We are dedicated to improving lives through science.
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