QA Manager Operations

CK QLS are recruiting for a QA Manager Operations, to join a leading pharmaceutical company, based in Basel, on a 12 month contract.

Responsibilities:

• Support a discipline and/or provide a service individually or within a team of associates. May provide functional expertise to the corresponding business partner (Line Unit) and other QA Units in area of responsibility.
• Write, review, decide on approval and/or release of GMP-relevant deliverables in order to ensure compliance with cGMP internal quality standards.
• Perform project related activities, e.g. TRD products portfolio, operational processes, Quality Risk Assessments.
• Support Project management functions as a project team member.
• Provide Quality Oversight and support to TRD line functions in GMP related topics as per area of responsibility.
• Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance, SOPs etc.).

Specific tasks Area of responsibility: TRD QA Operations Specific activities:

• Release of batches, materials and components for clinical trials with issuance of batch certificates, and approval of development documentation with the authority defined as per related governing SOPs, and with authorities delegated by the TRD Quality Team Head or QA Switzerland Site Head (FvP).

Background:

• Masters, 5 years in pharma quality.
• Languages: Fluent German and English required (oral & written) for 1 role / English.
• Fluent and German nice to have for the second open role. Experience/Professional requirement.
• Good knowledge of cGMP, working knowledge in technical development, production and QA.
• Sound scientific, technical and regulatory knowledge.
• Strong organizational and decision-making skills.
• Strong and proven ability to analyze and evaluate cGMP compliance.
• Solid QA experience.

Apply:

It is essential that applicants hold entitlement to work in Switzerland. Please quote job reference in all correspondence.