The Compliance Specialist will provide Quality support and expertise to the laboratories and ensure supply of quality pharmaceutical products in meeting the Merck Manufacturing Division (MMD) priorities of: Compliance, Supply, Strategy and Profit plan.
The Compliance Specialist will participate in the compliance program across Laboratory operations.
The Role will require assessment of changes, understanding the regulations and compliance around Laboratory programs. They will be actively involved in investigation and help to implement corrective & preventive actions within the department. The role will be support the Laboratory Operations department during Regulatory, corporate, and Internal audits.
- The team working style is one of collaboration, coaching and facilitating to provide Quality oversight and expertise to the laboratory team to support a High Performing Organisation.
Functions
- Deliver a robust Quality Management System to support a flexible, collaborate, multi-skilled teamwork environment.
- Provide independent quality support, guidance, and expertise to ensure the success of each area
- Support the review & approval of key quality deliverables across Laboratory Operations including Change Control, Deviations, & Safety
- Review & approval of GMP procedures (& associated documents)
- Responsible for Compliance Tier 4
- Supporting archiving for Laboratory Operations
- Participation in inspection of site by CQAC/Regulatory Bodies /third parties.
- Champion the highest quality and compliance standards for the Laboratory Operations
- Makes decisions within guidelines and policies which impact Laboratory Operations
- Champion the highest Quality and Compliance standards for Laboratory Operations
- Participate in GMP walkthroughs to ensure goodhouse keeping & safety standards.
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