Quality Assurance Manager

vor 14 Stunden


Fribourg, Schweiz Modis Vollzeit

We are recruiting, on behalf of our client, an experienced Quality Assurance Manager for the R&D department.

You have experience in quality assurance on a manufacturing site and collaborated closely with laboratories? You would like to join a dynamic environment and growing company?

We have the right opportunity for you

The company offers an international environment, the opportunity to work on medical products with high added value and the possibility to grow professionally.

**Main purpose of the role**:
Maintain and manage the R&D site's Quality Assurance (QA) activities in compliance with GMPs, ensuring a constant state of regulatory compliance and quality services.

**Responsibilities**:
Under the responsibility of the Quality and analytical development department manager, you will have to perform the following tasks:

- Manage the development, implementation and maintenance of Quality System
- Review/approve for issuance of quality documents (SOP’s, specifications protocols, reports..)
- Manage deviation with the concerned functions
- Manage corrective and preventive actions (CAPA) and participate to quality investigations
- Manage Change Control process: review and evaluate change control requests
- Review and approve validation and qualification protocols and reports, including CSV
- Review and approve stability protocols and reports
- Review batch records Participate to risk Analysis
- Manage annual quality training and training plan
- Manage suppliers and subcontractors
- Manage external audit and inspection from Regulatory Authorities
- Manage the Quality Assurance Manager Assistant
**Profile**:

- Bachelor, Master’s degree in Chemistry, Pharmacy, or Biochemistry
- At least 7 years of experience in QA environment within Pharmaceutical or Biotechnology industry
- Strong knowledge of cGMP regulations
- Excellent team player with a strong ability to communicate within a multicultural environment, at all organizational levels
- Fluency in English (both oral and written)
- Extremely motivated, with rigorous work habits and problem-solving skills
- Track record of successful inspection from regulatory authorities
- Knowledge and experience of GLP is an asset



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