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associate manager
3 months ago
Department Details
Role Summary
Associate manager - Quality assurance
Key Responsibilities
· Provide QA oversight during qualification of equipment and instruments, CSV (Computer Systems Validation), Facility, Smoke Study, HVAC and Utility of Injectable facility.
· To coordinate overall process validation program , packaging validation and review & approval of protocol and report.
· Handling of new Product Introductions and identification of associated process validation needs.
· To coordinate overall cleaning validation program and review & approval of protocol and report.
· Overall coordination for CPV program, review and approval of CPV monitoring plan.
· To prepare and review validation master plan.
· To review and approve software validation and PLC validation protocols and coordinate for execution.
· To ensure compliance to cGMP system and procedures related to production activities.
· Review and preparation of the Risk Assessment for green field injectable facility and associated manufacturing processes.
· Review of Equipment Breakdown's and closure with appropriate mitigation action and necessary impact assessment.
· Review and implementation of Regulatory guidelines with respect to qualification and validations.
· Review of media fill protocols and coordinate for execution with cross functional team.
· To handle QMS activities like Change Management, CAPA, Deviation and Investigations associated with manufacturing.
· Preparation and review of standard operating procedures and its timely implementation.
· To assist during regulatory audits.
Educational Qualifications
Required Education Qualification:
Required Experience: years
