Role Summary
To execute QMS investigations, documentation, and audit support — Market Complaints, Deviations, Change Controls, Incidents, Laboratory Incidents, CAPA, Returned Goods, and Product Recalls — under the QMS Senior Executive's guidance.
Key Responsibilities
1. Investigation Management
Conduct investigations related to Market Complaints, Deviations, Change Controls, Incidents, Laboratory Incidents, CAPA (Corrective and Preventive Actions), Returned Goods, and Product Recalls.
Document RCA and CAPA in QMS; track timeline-based closure.
Coordinate with QC, Production, Packing, F&D, Engineering for investigation inputs.
2. QMS Documentation
Supervise issuance, distribution, retrieval, and destruction of all QMS documents in accordance with company procedures.
Assist in preparation, review, and maintenance of Quality Assurance documentation.
Prepare and maintain key quality documents — Self-Inspection Plan, Site Master File (SMF), Validation Master Plan (VMP), Quality Manual.
Prepare, review, and maintain Quality Risk Management (QRM) documents.
3. cGMP Compliance & Audit Handling
Ensure effective implementation and adherence to cGMP at the manufacturing site.
Coordinate and support internal and external quality audits.
Prepare and review compliance reports following audits.
4. System Operations & Coordination
Perform assigned activities in the Quantum software system as per authorized user rights.
Coordinate with Junior Executives across QMS sub-functions for routine matters.
Train Junior Executives on investigation procedures and QMS documentation.
Systems to be Handled
QMS module (change control, deviation, OOS, OOT, CAPA, market complaint)
Validated software systems (Quantum or equivalent)
Document Management System (eDMS)
Documentation & Compliance
Follow ALCOA+ principles for data integrity.
Adhere to cGMP, ICH Q9 / Q10, and Schedule M norms.
Maintain SMF, VMP, Quality Manual, Self-Inspection Plan, QRM documents.
Participate in internal audits, regulatory inspections, and CAPA closure.
Support self-inspection of QMS records.
Qualification
B.Pharm / M.Pharm
Experience
3 – 5 years (OSD experience preferred)
Skills & Competencies
Strong QMS investigation expertise — Deviations, CAPAs, Market Complaints, Recalls.
Working knowledge of cGMP, ICH Q9 / Q10, Schedule M.
Strong technical writing for investigation reports, SMF, VMP, QRM.
ALCOA+ and data integrity rigour.
Validated software (Quantum or equivalent) proficiency.
Coordination across QC, Production, Packing, F&D, Engineering.
