Key Responsibilities
Quality Management Systems
- Manage and review Quality Management System (QMS) activities including Deviations, CAPA, Change Controls, OOS/OOT investigations, Risk Assessments, and SOP management.
- Ensure compliance with cGMP, ICH, USFDA, EU GMP, WHO GMP, and other applicable regulatory requirements.
- Review and approve quality documents, protocols, reports, and GMP records. Batch Review & Product Release
- Review Batch Manufacturing Records (BMR), Batch Production Records (BPR), cleaning records, and supporting documentation.
- Ensure timely batch disposition and release of APIs and intermediates.
- Verify compliance of manufacturing activities with approved procedures. Investigation & Compliance
- Lead investigations for deviations, OOS, OOT, customer complaints, and market complaints.
- Perform root cause analysis and implement effective CAPAs.
- Monitor CAPA effectiveness and compliance timelines. Validation & Qualification
- Review and approve validation documents related to:
- Process Validation
- Cleaning Validation
- Equipment Qualification (IQ/OQ/PQ)
- Analytical Method Validation
- Computer System Validation
- Ensure validation activities comply with regulatory expectations. Audit Management
- Participate in and support regulatory inspections, customer audits, and internal audits.




- Prepare responses to audit observations and ensure timely closure of commitments.
- Conduct GMP audits and self-inspections. Documentation & Data Integrity
- Ensure adherence to ALCOA+ and Data Integrity principles.
- Review GMP documentation for completeness and compliance.
- Support electronic and paper-based documentation control systems. Training & Team Management
- Conduct GMP, Data Integrity, and Quality System training programs.
- Mentor junior QA personnel and support cross-functional teams.
- Drive quality culture initiatives across the organization. Required Skills
- Solid knowledge of cGMP, ICH Guidelines, USFDA, EU GMP, WHO GMP regulations.
- Expertise in Deviation, CAPA, Change Control, OOS/OOT, and Risk Management.
- Experience in handling regulatory and customer audits.
- Knowledge of Data Integrity requirements and quality systems.
- Proficiency in documentation review and batch release processes.
- Good analytical, leadership, communication, and problem-solving skills. Preferred Experience
- Minimum 10 years in Quality Assurance within API/Bulk Drug manufacturing.
- Exposure to USFDA, EDQM, PMDA, MHRA, TGA, and WHO-regulated facilities.
- Experience in TrackWise, SAP, Veeva, MasterControl, or similar QMS platforms.
- Successful participation in regulatory inspections and customer audits.

📌 Quality Assurance Incharge (Hyderabad)
🏢 Vasudha Pharma Chem
📍 Hyderabad