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.
