Quality Assurance Manager (a)
Michael Page
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About Our Client
Our client is a medium-sized company operating in the LIFE SCIENCES sector. They are committed to innovation and maintaining the highest standards of quality in their field.
Key Details
* International biotech company
* 6 months contract with extension option
Job Description
* Ensure compliance with regulatory standards and company policies in the LIFE SCIENCES industry.
* Review and approve all PPQ related documentation (protocols, reports, discrepancies, etc.).
* Review executed PPQ batch records and ensure accurate transcription to reports.
* Ensure any execution discrepancies are properly investigated and impact to PPQ is assessed.
* Participate in FMEA or other risk-based approaches to assess process performance.
* Provide regular updates on PPQ progress and escalates challenges (PPQ failures, delays) in a timely manner.
* Act as main quality contact on project teams, escalating as appropriate and seeking cross functional alignment and clarifications as needed to ensure product quality.
The Successful Applicant
* Degree in a relevant field, such as Life Sciences or a related discipline.
* 3-5 years of experience in Quality / Process Validation.
* Strong knowledge of Good Manufacturing Practices (GMP), specifically for small molecule drug substance and drug product operations.
* Ability to effectively manage time, multiple overlapping priorities and progress tasks to meet timeline in a fast pace/dynamic environment.
* Experience working cross-department with CMC, regulatory, MSAT and other quality functions across multiple countries / time zones.
* Ability to evaluate and understand quality risk, including risk mitigation.
* Business fluency in English.
What's on Offer
* An opportunity to contribute to impactful projects in the LIFE SCIENCES industry.
* A collaborative and professional work environment in BASEL with a hybrid work option.
* Comprehensive onboarding and training for a seamless start.
* Access to resources and tools to support your professional development.
Contact: Kamila Fotiou
Quote job ref: JN-112025-6894018
Seniority level: Mid-Senior level
Employment type: Contract
Job function: Science and Health Care Provider
Industries: Biotechnology
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