Designation : Senior Executive / Assistant Manager
No of Positions : 2
Edu. Qualification : B.Pharm / M.Pharm / M.Sc (Life Sciences / Chemistry / Microbiology)
Experience : 7–10 years of experience in pharmaceutical Quality Assurance with a strong focus on QMS
Prior experience in facing regulatory audits (e.g., USFDA, EU-GMP, MHRA)
Work Location : Gummidipoondi, Injectable plant.
Job Purpose
To lead the implementation, monitoring, and continuous improvement of the site Quality Management System (QMS) in compliance with current Good Manufacturing Practices (cGMP), regulatory standards (USFDA, MHRA, WHO, EU-GMP), and internal company quality policies.
Key Responsibilities
Lead the administration of QMS elements including: Deviations, Change Controls, CAPA, Market Complaints, Risk Management, and Quality Metrics.
Review and approve QMS-related documentation ensuring alignment with regulatory expectations.
Facilitate and drive timely closure of quality events with cross-functional coordination.
Prepare the site for regulatory, third-party, and internal audits.
Act as QA representative during audits, providing responses and managing post-audit CAPAs.
Ensure robust audit preparedness and support mock audits and gap assessments.
Oversee issuance, revision, and archival of controlled documents (SOPs, protocols, reports).
Ensure strict adherence to document lifecycle and data integrity policies.
Conduct training for QA/QMS personnel and cross-functional teams on QMS elements and GMP.
Drive initiatives for continual improvement and quality culture reinforcement.
Participate in risk assessments and periodic product quality reviews (PQR/APQR).
Lead risk mitigation actions and ensure integration into QMS processes.
Mentor and guide QA officers and executives in day-to-day QMS operations.
Ensure team compliance with timelines and KPIs.