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
1. 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.
2. 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.
3. 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.
