1.To review of QC, stability /ADL related documents.
2.To participate in OOS / Deviation / Out of calibration investigations / Incidents / OOT / OOAL.
3.To prepare and review Trend analysis, stability reports.
4.System Administration control along with IT for QC/ADL instrument and equipment.
5.To review analytical data through application software/ hard copy, randomly.
6.To monitor calibration and preventive maintenance of QC/ADL Instrument and equipment as per schedule.
7.To review /approve stability protocol/schedule /Analysis data/stability study report.
8.System monitoring of QC / ADL on daily basis.
Preferred candidate profile
- M.Sc.(Chemistry)/B. Pharma. / M.Pharm. or equivalent qualification.
- 0507 years of relevant experience in API Quality Assurance in a USFDA/EU-approved pharmaceutical manufacturing facility.
Key Competencies
- Solid knowledge of cGMP, regulatory compliance, QC/ADL oversight, data integrity (ALCOA+), analytical data and stability review, OOS/OOT/OOAL and deviation investigations, trend analysis, laboratory instrument and computerized system controls, risk assessment, CAPA management, and effective documentation review and cross-functional coordination.
- To maintain an effective and compliant API Quality Management System through proactive quality oversight, robust investigations, effective CAPA, controlled documentation, customer satisfaction, regulatory compliance, and continual improvement.