CQA - Corporate Quality Assurance Pharma

As a skilled QA Executive / Officer joining the Quality Assurance team, you will be responsible for various key tasks including: - Conducting gap analysis against QA SOPs, preparing and revising SOPs using Control Document Management System (CDMS), and conducting classroom training sessions for approved SOPs. - Preparing annual internal audit schedules, conducting internal audits, and preparing audit reports. Raising CAPAs in TrackWise and verifying effectiveness post-implementation. - Preparing Periodic Product Review (PPR) for assigned products as per regulatory expectations. - Supporting contract manufacturing sites during product transfers and validations. - Performing change control assessments from a validation perspective, preparing and maintaining Site Validation Master Plan (SVMP), presenting monthly validation reports to the steering committee, and tracking and managing re-qualification schedules. - Preparing protocols and reports for cleaning validation, conducting Clean Equipment Hold Time (CEHT) & Dirty Equipment Hold Time (DEHT) studies. - Conducting gap analysis against QMS standards, handling and documenting change controls, deviations, and CAPAs, and performing risk assessments for process changes or new product introductions. Interview Details: - Walk-in Interviews: Monday to Friday, 2:00 PM 4:00 PM. Please carry your updated resume and passport-size photograph. Interview Address: Unit G-14, 15, 16, 17, PRABHADEVI INDUSTRIAL ESTATE, 408, Swatantryaveer Savarkar Rd, Prabhadevi, Mumbai, Maharashtra 400025. Job Type: Full-time Experience: Relevant - 5 years (Required) Expected Start Date: 01/08/2025,