Role Summary
To manage QC documentation control and support compliance activities — ensuring proper issuance, review, and control of documents along with GMP / GLP compliance and data review support.
Key Responsibilities
- Document Control
- Control issuance, revision, retrieval, and archival of QC documents — SOPs, STPs, specifications, logbooks, worksheets, MOA — per controlled document register.
- Maintain document cell registers — issuance, retrieval, archival, change history.
- Coordinate and ensure training of QC personnel on revised SOPs / specifications / MOA before effective dates.
- Data Review & Compliance
- Review and verify analytical data from instruments such as HPLC, UV-Vis spectrophotometer, pH meter, KF auto-titrator, and balances — for completeness, signatures, calculations, and ALCOA+ compliance.
- Ensure testing is performed as per approved specifications and SOPs; flag any deviation in execution to supervisor.
- Verify SOP implementation and compliance across QC sections through periodic walkthroughs and document checks.
- Monitor GMP / GLP compliance in QC departments and follow up for corrective actions on observed gaps.
- Investigation Support
- Support investigation of OOS, OOT, and laboratory incidents — gather raw data, chromatograms, instrument logs, and analyst notes for investigation files.
- Support continuous improvement initiatives in documentation and quality systems — paperless lab, e-logbook, LIMS adoption.
Equipment / Systems to be Handled
- Document Management System (eDMS)
- QMS modules
- Logbooks (HPLC, UV, pH meter, KF auto-titrator, balances)
Documentation & Compliance
- Follow ALCOA+ principles for data integrity.
- Adhere to cGMP, GLP, and Schedule M norms.
- Maintain logbooks, test records, and protocols as per SOPs.
- Participate in internal audits, regulatory inspections, and CAPA closure.
- Ensure calibration and preventive maintenance of equipment is up to date.
Qualification
B.Sc / M.Sc / B.Pharm
Experience
1 – 3 years; (OSD experience preferred).
Skills & Competencies
- Strong technical writing — specifications, MOA, RDS, SOP per ICH Q6A.
- Knowledge of cGMP, GLP, GDP, and ALCOA+ for QC.
- QMS proficiency.
- Coordination across QC sections, QA, and RA.
- Audit-readiness.
