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