Job Description
The Associate Director Operations Support, Laboratory Operations, reports to the Director Laboratory Operations and provides operations support to the Laboratory Operations of our organisation. Directs all aspects of the operations support activities within Laboratory Operations including stability program management, contract testing laboratory oversight, GMP compliance for vaccine drug substance and drug product testing including compendial compliance, change control, documentation control and inspection readiness. Ensures that products are tested in compliance with all regulatory guidelines and standard and facilitates innovation and continued improvement.
Primary Activities (Primary activities include, but are not limited to):
• Provides direction and leadership to the operations support team in the laboratories. Key activities include Stability program management, contract testing laboratory oversight and GMP compliance for vaccine drug substance and drug product testing.
• Ensures that the laboratories execute testing compliant with external regulatory guidelines, compendia, and internal GMP standards. This includes testing programs for raw materials,...
Merck Sharp & Dohme LLC
A pharmaceutical company focused on quality control and regulatory compliance.
Updated
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