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QA Operations Manager
vacancy for our Basel based client in the Pharma sector.
Your Tasks
* Manage complex projects and processes to support drug development portfolio, production, and life cycle management.
* Ensure compliance with cGMP standards and internal quality requirements.
* Write, review, and approve GMP-relevant deliverables.
* Provide quality oversight to line functions in GMP-related topics.
* Support project management functions as a project team member.
* 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)
* Oversight on the review of master and executed batch records performed by the QA specialists, including clarification of all deficiencies in GMP documents, and supervision of agreed follow-up.
* Write, review, and complete GMP relevant documents (e.g. CoAs, BRR checklists, SOPs, risk assessments).
* Supports audits and inspections in case of questions on assigned projects
* QA SPOC for assigned CMO. In this context, supports on-site visits and audit preparations at CMO, follows up audit CAPAs, and supports review of CMO KPIs and input to Quality agreements.
* Also responsible for collecting feedback from the various QA managers and support preparation of the Quality Risk Assess-ment (QRA).
* Is informed about deviations/OOX, general issues and changes at the CMO, and follows up at the corresponding meetings.
* Helps the QA managers and specialists for specific questions on CMO batch records/documentation and helps keeping harmonization of TRD QA Ops response.
* Deputize for peers in the same area of responsibility Masters or 5 years in pharma quality experience
Your Experience/knowledge
* Masters or 5 years in pharma quality experience.
* Experience in a technical R&D environment (pharma/chemical) is preferred.
* Good knowledge of cGMP and experience in technical development, production, and QA.
* Strong scientific, technical, and regulatory knowledge.
* Language skills: English – fluent, German – nice to have.
Your Soft Skills
* 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.
Location:
Basel, Switzerland
Work setting:
On-site
Sector:
Pharma
Start:
01/10/2025
Duration:
12+ months
Workload:
100%
Ref.Nr.:
BH 23452
Take the next step and send us your resume along with a daytime phone number where we can reach you.
Due to Swiss work permit restrictions, we can only consider applications from Swiss nationals, EU citizens, and current work-permit holders for Switzerland.
We welcome applications from individuals of all genders, age groups, sexual orientations, personal expressions, ethnic backgrounds, and religious beliefs. Therefore, there is no requirement to provide gender information or a photo in your application.
As per client requirements, we need information about your marital status, nationality, date of birth, and a valid Swiss work permit. For applicants with disabilities, we are happy to explore potential solutions with our end client.