CQA - Corporate Quality Assurance Pharma

We are seeking a skilled QA Executive / Officer to join our Quality Assurance team. The ideal candidate will have hands-on experience in SOP preparation, internal audits, validation, cleaning validation, and quality systems (QMS). Key Responsibilities: - SOP Preparation, Revision & Training: Conduct gap analysis against QA SOPs, prepare and revise SOPs using Control Document Management System (CDMS), and conduct classroom training sessions for approved SOPs. - Audit & Inspection Readiness: Prepare annual internal audit schedules, conduct internal audits, and prepare audit reports. Raise CAPAs in TrackWise and verify effectiveness post-implementation. - Periodic Product Review (PPR): Prepare PPR for assigned products as per regulatory expectations. - Product Transfer & Validation Support: Support contract manufacturing sites during product transfers and validations. - Qualification Activities: Perform change control assessments from a validation perspective, prepare and maintain Site Validation Master Plan (SVMP), present monthly validation reports to the steering committee, and track and manage re-qualification schedules. - Cleaning Validation: Prepare protocols and reports for cleaning validation, conduct Clean Equipment Hold Time (CEHT) & Dirty Equipment Hold Time (DEHT) studies. - Quality Management Systems (QMS): Conduct gap analysis against QMS standards, handle and document change controls, deviations, and CAPAs, and perform 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,