Senior Executive / Assistant Manager – QA QMS

Caplin Steriles Pvt Ltd; Thiruvallur District; On-site; INR 8,000,000 - 12,000,000; Full time

Job summary

A pharmaceutical company in Thiruvallur District is seeking a Senior Executive or Assistant Manager for Quality Assurance. The role involves leading the implementation and improvement of the Quality Management System, ensuring compliance with regulatory standards, and facilitating audits. The ideal candidate should have 7-10 years of experience in QA, particularly in pharmaceuticals, and a strong background in regulatory compliance. This position offers opportunities to mentor a team and drive quality initiatives.

Qualifications

• 7–10 years of experience in Quality Assurance in pharmaceuticals.
• Strong focus on QMS and regulatory compliance.
• Experience facing regulatory audits like USFDA and MHRA.

Responsibilities

• Lead the implementation of Quality Management System.
• Review and approve QMS-related documentation.
• Act as QA representative during audits.

Skills

Pharmaceutical Quality Assurance

Quality Management System (QMS)

Regulatory Audits (e.g., USFDA, EU-GMP)

Cross-functional Coordination

Education

B.Pharm / M.Pharm / M.Sc (Life Sciences / Chemistry / Microbiology)

Job description

Designation

Designation: Senior Executive / Assistant Manager

No of Positions

No of Positions: 2

Educational Qualification

Edu. Qualification: B.Pharm / M.Pharm / M.Sc (Life Sciences / Chemistry / Microbiology)

Experience

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

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.