Role & responsibilities 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.

📌 Executive -Lab QA-Quality Assurance-Peptide API-Raks Pharma, Dahej
🏢 Raks Pharma(Dahej) A div. Amneal Pharmaceuticals
📍 Dahej