QA Manager GVP - Biotech (m/f)
View: 192
Update day: 24-04-2024
Location: Basel Basel-Stadt BS
Category: Science Labor Health / Medical Care
Industry: Information Technology Services Staffing Recruiting Financial Services
Position: Mid-Senior level
Job type: Full-time
Job content
- International Biotech Company|Career progression
I am currently supporting an international Biotech company who is currently creating a new position as Manager QA GVP as they are in constant growth.
Job Description
- Ensuring quality oversight and support of the PV activities
- Building and developing the audit strategy, program and plans within the PV area
- Being the SOP Author for SOPs related to GVP audits including supporting documents
- Performing SOP approval within R&D and Medical Affairs area (excluding CMC part)
- Preparing the GVP audit strategy and the audit programs according to SOPs.
- Ensuring audits are performed with internal auditors and external auditors as needed
- Preparing budget and budget follow-up for costs related to audits performed by contractors
- Preparing regular status report on performed audits, audit trending and agreed upon metrics to ensure Quality oversight
- Degree in Life Sciences
- Few years of experience in the Pharmaceutical industry with GCP/GVP responsibilities
- Experience working with GVP audits/inspections
- Know-how of the EU/US/RoW regulations within GVP
- Fluent in English
By joining this company, you will be able to evolve in an environment where the career development is visible, you will be part of passionate QA team, innovative and growing Biotech company
Contact: William Dubar
Quote job ref: JN-112021-4511072
Deadline: 08-06-2024
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