International biotech company
6 months contract with extension option
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.
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 escalate challenges (PPQ failures, delays), timely
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 understands quality risk, including risk mitigation
Business fluency in English
What's on Offer
Our client offers you:
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
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