QA Manager - Service Providers Qualification

Randstad Professionals is seeking a Senior Quality Manager for their client in Kaisreaugst, Basel.  As a Quality Manager Inspection Readiness you are responsible for the inspection readiness of the Drug Products Manufacturing Basel. Main focus is the parenterals production.

Your responsibilities include primarily:

- Creation of a comprehensive list of Service Providers and Suppliers within the Basel and Kaiseraugst organization.
- Provide Audit Reports within the company's Network.
- Develop a consistent terminology when dealing with Service Providers and Suppliers.
- Finalize the risk assessments based on the list of Service Providers and Suppliers within the Basel and Kaiseraugst organization.
- Implement Inspection Readiness procedures and ensure inspection readiness for Basel parenterals production
- Implement "Inspection Readiness" training for managers and groups
- Implement a process and procedure for managing know-how within Quality between experts and different functions in order to create a high level of flexibility and expertise.
- Implement and ensure QCS procedures and improve QCS awareness of all business partners and users.
- Plan and execute QCS training and use of scorecard for managers and groups
- Perform readiness mock inspections at the site
- Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance

As Quality Manager you support inspections of the drug product manufacturing. Your responsibilities include primarily

- Responsibility for own implementation, documentation and tracking of self-inspections
- Co-ordination, documentation and tracking of government and customer inspections
- Ensuring the readiness inspection at the site regarding regulatory requirements
- Implementation of audit and inspection training

General Tasks:

- Provide production and quality departments input to thereview and approval of manufacturing and Quality related documents.
- Review of GMP documents as requested.
- Publish Inspection Readiness Scorecard and communicate current state of inspection readiness to Senior Management.
- Review current 483 observations and warning letters to monitor the inspection climate.
- Participate in post-inspection activities including observation response process and commitment follow-up and tracking.

Job Profile:

- University degree in pharmacy, microbiology, chemistry or biochemistry or a similar training (eg, Quality Engineer)
- Several years of professional experience in the pharmaceutical parenterals production and/or quality assurance and/or Quality Management
- Sound knowledge of international GMP experience
- Depth knowledge of FDA specific regulatory requirements
- Depth knowledge in Inspection Readiness Procedures
- Depth Auditing experience
- Team player and a communicative personality
- Assertiveness and initiative is a must
- Thorough and independent way of working
- In-depth knowledge of documentation systems and computer skills.
- Very good oral and written English skills