
Senior Product Quality Expert
2 weeks ago
We are seeking a skilled Product Quality Specialist to join our team. This role plays a critical part in ensuring compliance and quality within the organization.
Main Responsibilities- Perform thorough reviews of third-party product documentation, including technical documents and prepare batches for certification.
- Review and maintain Product Specification Files to ensure accuracy and compliance.
- Manage batch review trackers, ensuring timely allocation of work across the QA team.
- Raise and manage Events, Deviations, CAPAs, and Non-Conformance Reports in a timely manner, escalating to management as required.
- Generate and report compliance metrics related to batch record review and preparation, ensuring continuous monitoring of QMS effectiveness.
- Support the investigation and resolution of internal and external quality issues using risk management principles.
- Author, review, and update SOPs, work instructions, and controlled documents.
- Partner with Project Managers, colleagues to drive timely resolution of batch-related issues and corrections.
- Collaborate effectively across departments to ensure alignment and timely delivery of objectives.
- Science Qualification, Degree and/or relevant experience is required.
- 2 to 3 years of sterile experience in a manufacturing setting with good technical knowledge.
- 7+ year's QA Experience in pharmaceutical or medical device is required.
This role offers a challenging and rewarding environment with opportunities for growth and development.
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Product Quality Expert
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