GMP Compliance Specialist
3 days ago
Role Summary
The Quality Operation Specialist is responsible for ensuring site compliance with GMP requirements and corporate policies and procedures. This role involves reviewing and approving GMP documents, collaborating with operations teams, and coordinating shop floor routine compliance.
Key Responsibilities
- Ensure timely delivery of quality oversight relevant activities that maintain GMP compliance in shopfloor, engineering, and warehouse environments.
- Review and approve all GMP documents from functional teams.
- Collaborate with operations teams to resolve problems and improve processes.
- Coordinate shop floor routine compliance and ensure all time readiness of sites for GMP and client audits.
- Participate in deviation and OOS investigation as a quality representative.
- Involved in process validation and clean validation quality review and approval.
- Establish QA Operations procedures and continually seek ways to improve them.
Requirements
To be successful in this role, you will require:
- A Bachelor's Degree in Life Sciences or Chemical/Biochemical Engineering, or a related scientific field.
- At least 3 years of experience in Quality Assurance, preferably in pharmaceuticals.
- Knowledge of cGMP and Regulatory Compliance, as well as Quality Management Systems.
- Effective systematical thinking and communication skills.
- Good teamwork and partnership abilities.
- Results-oriented approach with strong problem-solving and Quality Risk Management knowledge.
About Us
Thermo Fisher Scientific is a world leader in serving science, empowering our colleagues to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions.
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