
Senior MES Quality Assurance Specialist
2 weeks ago
Job Summary
This role involves overseeing the preparation and review of MES & other GMP software qualification documents. The successful candidate will be responsible for preparing URS, GxP risk assessments, qualification protocols (OQ, PQ), RTM, and VSR, as well as reviewing URS, RA, design documents, and qualification documents. They will also handle post-implementation changes documents, execute OQ and PQ, and prepare compliance reports for internal/external audits and compliance of internal/external audit points.
About This Role
- Qualification Protocol (OQ) Execution
- GxP Risk Assessment Preparation
- Documentation Review and Approval
- Change Control Management
- Quality Assurance and Quality Control
- MES and GMP Software Qualification
What We Offer
- A challenging and rewarding work environment
- Opportunities for career growth and development
- A competitive salary and benefits package
- A collaborative and dynamic team
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