Job Summary

We are looking for a detail-oriented and experienced Quality Assurance qualified to join our Parenteral manufacturing facility. The ideal candidate will have hands-on working knowledge of regulatory and quality compliance systems and will be responsible for supporting day-to-day Production operations as listed below,in line with cGMP and regulatory requirements.

Key Responsibilities

•Handle and manage e-QMS (Electronic Quality Management System) related activities and documentation.

•Coordinate and monitor LMS (Learning Management System) for employee training compliance.

•Manage documentation through DMS (Document Management System), ensuring version control and timely approvals.

•Initiate, evaluate, and implement Change Controls in line with regulatory requirements.

•Investigate and close CAPA (Corrective and Preventive Actions) within defined timelines.

•Handle Deviation management including root cause analysis, risk assessment, and closure.

•Ensure compliance with cGMP, regulatory guidelines, and internal quality standards applicable to parenteral products.

•Support internal and external audits (regulatory, customer, and third-party audits).

•Coordinate with cross-functional teams (QA, QC, Regulatory Affairs, Engineering)



to ensure quality compliance.

Required Skills & Qualifications

- B. Pharmacy is mandatory; M. Pharmacy will be an added advantage. •Minimum 2 years of relevant experience in Quality Assurance within a Parenteral

(injectable) pharmaceutical manufacturing company.

•Working knowledge of e-QMS, LMS, DMS, PQR, Change Control, CAPA, and Deviation management systems.

•Sound understanding of cGMP, GDP, and other applicable regulatory compliance requirements (USFDA / MHRA / WHO-GMP, as applicable).

•Good documentation practices (GDP) and strong attention to detail.

•Effective communication, coordination, and interpersonal skills.

•Proficiency in MS Office (Word, Excel, PowerPoint).

•Ability to work effectively within a team and under regulated timelines.

Preferred / Additional Skills

•Prior exposure to sterile / aseptic manufacturing processes.

•Experience with audit readiness and handling regulatory inspections.

•Knowledge of Quality Risk Management (QRM) tools such as FMEA.

•Exposure to Annual Product Quality Review (APQR) preparation.

Aishwarya HR [email protected] (phone hidden)

📌 Executive Officer Production with QA background (Mumbai)
🏢 BVR People Consulting
📍 Mumbai