Analytical Method Validation

Plan, execute, and document analytical method validation (accuracy, precision, specificity, linearity, robustness, LOD/LOQ, etc.) for raw materials, in-process samples, finished products, and cleaning validation.Review and approve validation protocols and reports in compliance with ICH Q2(R1), USP, and other regulatory requirements.Ensure all AMV activities meet GMP, GLP, and cGMP guidelines.Coordinate with R&D, QA, and Production teams for smooth tech transfer and validation support.Troubleshoot analytical method issues and recommend improvements or revalidations when necessary.Maintain and calibrate analytical instruments (e.g., HPLC, GC, UV-Vis, FTIR).Prepare for and participate in regulatory inspections and internal audits.Train and mentor junior QC staff on method validation procedures and regulatory expectations.Ensure all documentation is complete, accurate, and archived as per SOPs.

**Note**

**Joining Required**:Immediate Joiner Required

**Educational Qualification**: B.Pharm / M.Pharm / MSc (Analytical Chemistry or equivalent)

Qualifications and Experience:Education: B.Pharm / M.Pharm / MSc (Analytical Chemistry or equivalent)Experience: Minimum 5-7 years in QC with at least 2-3 years specifically in AMV for sterile injectable formulations.Strong hands-on experience with HPLC, GC, UV, and other analytical techniques

**Job Types**: Full-time, Permanent

Pay: From ₹20,000.00 per month

**Benefits**:

- Food provided
- Paid sick time

Schedule:

- Weekend availability

Supplemental Pay:

- Overtime pay
- Yearly bonus

Work Location: In person