Key ResponsibilitiesAnalytical Testing
- Perform routine and non-routine analysis of:
- Raw materials
- In-process samples
- Finished products
- Stability samples
- Conduct analysis using HPLC, GC, UV, IR, Dissolution, KF, and Wet Chemistry techniques.
- Ensure compliance with approved specifications, STPs, and pharmacopoeial standards (USP, EP, IP, BP).

Documentation & Data Integrity
- Maintain complete and accurate analytical records as per GDP & ALCOA+ principles.
- Review and approve raw data, worksheets, and test reports.
- Prepare and revise SOPs, STPs, and analytical methods.
- Ensure proper handling of OOS, OOT, deviations, and CAPA.

Instrument Handling & Calibration
- Operate, calibrate, and maintain QC instruments.
- Ensure instruments are qualified, calibrated, and within validity.
- Coordinate with Engineering / external agencies for calibration and maintenance.

Stability & Method Activities
- Execute and monitor stability studies as per ICH guidelines.
- Support method validation, method transfer, and verification activities.




- Participate in cleaning validation and cross-contamination studies.

Regulatory & Audit Support
- Support USFDA, MHRA, WHO, TGA, and customer audits.
- Prepare audit data, respond to observations, and implement CAPA.
- Ensure QC laboratory readiness at all times.

Safety & Training
- Follow EHS and laboratory safety guidelines.
- Train junior chemists and analysts on SOPs, GMP, and analytical techniques.
- Ensure proper chemical handling, waste disposal, and lab housekeeping.

Educational Qualification
- B.Sc / M.Sc (Chemistry):
- B.Pharm / M.Pharm:
- Training in GMP & FDA regulations preferred

Experience
- 1-6 years experience in a USFDA-approved QC laboratory:
- Exposure to formulation / API / injectables / OSD (as applicable)

Key Skills & Competencies
- Strong knowledge of USFDA, cGMP & Data Integrity:
- Hands-on experience with HPLC / GC / Dissolution / Stability:
- Expertise in OOS/OOT investigation:
- Positive documentatio

📌 Chemist Qc (Ankleshwar)
🏢 Basic Pharma Life Science
📍 Ankleshwar