Quality Assurance Manager - GMP (M/F)
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland and listed on the SIX Swiss Exchange (SIX: BSLN). It focuses on products that address increasing resistance and non-response to current treatment options in the therapeutic areas of bacterial infections, fungal infections and cancer. The company uses the integrated research, development and commercial operations of its subsidiary Basilea Pharmaceutica International Ltd. to discover, develop and commercialize innovative pharmaceutical products to meet the medical needs of patients with serious and potentially life-threatening conditions.
To strengthen our Quality Unit Department, we are looking for a motivated
Quality Assurance Manager - GMP (M/F)Your tasks
- Perform external supplier audits, select suppliers, and establish and maintain technical agreements
- Ensure overall GMP compliance for products in the development phase and in the commercial phase, and support GDP QA activities of commercial products
- Approve quality relevant documents for assigned products, setting and control of specifications, assess deviations, investigations, OOS and CAPAs and support change control, review and approve protocols/reports for GMP stability studies
- Prepare documentation package for certification of CTMs/MMPs of assigned products including contact to Qualified Persons of contractors, approve/reject material for human use and issue certificates
- Prepare relevant parts of CMC chapters for registration files and establish Annual Product Review / Product Quality Review
- Establish and update GMP related QMS documents
- Support budgeting and cost control of assigned tasks
- Training and support for Document Management System (PUMA) users and for the Learning Management System (LMS)
- University degree in pharmacy, chemistry, chemical engineering or equivalent is required, PhD degree is an asset
- Minimum 5 years of experience in the pharmaceutical industry and minimum of 3 years in a QA environment
- Experience in QA with products for human use
- Experience in Quality Control and in aseptic manufacture is desired
- Knowledge in Health Authority (FDA) inspections and in writing sections of regulatory documents is an advantage
- Proficient use of IT tools, MS Office is required, experience with SAP is an asset
- Good communication skills
- Ability to work in different cultural environment
- Team-oriented, flexible personality, who is able to work independently and to multi-task
- Fluent in written and spoken German and English
We offer an interesting and varied work environment in a dynamic future-oriented enterprise with a highly motivated team, a competitive salary and benefits.
We look forward to receiving your online application including your complete documents. For additional information please contact Ms Nadine Pfrüner.