Role & responsibilities:

- Lead and maintain the Quality Management System (QMS) and Document Control System in accordance with cGMP and regulatory requirements.
- Prepare, review, issue, revise, archive, and control quality documents, including SOPs, specifications, protocols, reports, and quality records.
- Ensure compliance with global regulatory requirements, including USFDA, MHRA, EU GMP, WHO GMP, and applicable regulatory guidelines.
- Quality management software and electronic systems such as TrackWise, Documentum, SAP, LMS, and other computerised quality systems.
- Investigate deviations, non-conformance, and quality events using appropriate Root Cause Analysis (RCA) tools and ensure timely closure.
- Review and investigate market complaints to identify root causes and recommend appropriate corrective and preventive actions.
- Participate in Out of Specification (OOS) and Out of Trend (OOT) investigations, including manufacturing investigations, and ensure scientifically justified conclusions.
- Manage the CAPA lifecycle, including initiation, implementation, tracking, effectiveness verification, and timely closure.




- Coordinate Change Control activities and ensure effective communication with cross-functional teams throughout the change management process.
- Support product recalls, mock recalls, Field Alert Reports (FARs), and regulatory submissions as applicable.
- Plan and participate in internal audits, compliance audits, and regulatory inspections, ensuring timely resolution of observations.
- Organize Quality Management Review (QMR) meetings, prepare quality metrics, analyze trends, generate reports, and monitor action item completion.
- Monitor quality performance indicators and recommend continual improvements to strengthen the Quality Management System.
- Ensure compliance with Valuable Documentation Practices (GDP), Data Integrity principles, and company quality policies.
- Collaborate with Manufacturing, Quality Control, Regulatory Affairs, Engineering, Supply Chain, and other cross-functional teams to maintain an effective pharmaceutical quality system.

📌 QMS Manager/Sr.Manager - Quality Assurance, Formulation (Vadodara)
🏢 Alembic Pharmaceuticals
📍 Vadodara