Role Summary
To support the QMS team in routine documentation, investigation file compilation, and QMS module data entry — and to learn QMS workflows from the ground up.
Key Responsibilities
1. Documentation Support
- Help senior team in typing, formatting, and version control of QMS documents — change controls, deviations, investigation reports, CAPAs.
- Help in collating draft documents, circulating for review, and tracking signatures.
- Help in archiving completed QMS records per retention schedule.
2. Investigation File Support
- Help in compiling investigation files for Market Complaints, Deviations, Incidents, OOS / OOT, CAPA.
- Help in retrieving BMR pages, logbooks, raw data for investigation files under senior verification.
- Help in tracking timeline-based closure of QMS records.
3. Records Maintenance
- Maintain QMS document registers — issuance, retrieval, archival — under supervision.
- Track training completion records of QA personnel on revised SOPs.
- Support self-inspection prep — retrieve documents, organize files, mark observations.
Systems Familiarity
- QMS module (read-only access initially)
- Document Management System (eDMS)
- Training tracker
Documentation & Compliance
- Follow ALCOA+ principles in all data entries (under senior verification).
- Adhere to confidentiality, cGMP, and Schedule M norms.
- Adhere to office and lab safety SOPs.
Qualification
B.Pharm / / M.Pharm
Experience
0 – 1 year (OSD experience preferred).
Skills & Competencies
- Basic understanding of QMS workflows.
- Office discipline and ALCOA+ data entry.
- MS Office and eDMS basics.
- Attention to detail.
- Willingness to learn and grow into a Junior Executive role.
