We are looking for a highly skilled QC Incharge – AMV to lead Analytical Method Validation activities in a WHO-GMP compliant pharmaceutical manufacturing facility. The role involves end-to-end ownership of method validation, troubleshooting, and ensuring compliance with global regulatory guidelines.
Key Responsibilities
- Lead Analytical Method Validation as per ICH Q2(R2) (Assay, Dissolution, Related Substances, Content Uniformity, etc.)
- Prepare and review validation protocols & reports
- Perform method development / optimization when required
- Handle method transfer from R&D / external labs
- Troubleshoot analytical issues (especially dissolution & impurity methods)
- Ensure compliance with IP / USP / BP pharmacopoeial requirements
- Review STPs, specifications, and analytical data
- Coordinate with QA, Production, and Stability teams
- Support process validation (PV) and investigation activities (OOS/OOT)
- Maintain GLP and data integrity within the lab
Key Skills & Expertise
- Strong hands-on experience in HPLC, GC, UV, Dissolution apparatus
- Deep understanding of validation parameters: accuracy, precision, linearity, robustness, specificity
- Experience in handling regulatory audits (WHO-GMP preferred)
- Strong troubleshooting and analytical thinking ability
- Good documentation practices (protocols, reports, STPs)
What We’re Looking For (Important)
- Someone who can build and lead AMV function, not just execute tests
- Strong ownership mindset
- Ability to guide junior analysts and improve lab capability
Qualification & Experience
- M.Sc / B.Pharm / M.Pharm
- 5–8 years experience in QC, with core focus on AMV
- Experience in solid oral dosage forms (tablets/capsules) preferred
Candidates with only routine QC/testing experience and no exposure to method validation are not suitable for this role.
Job Types: Full-time, Permanent
Pay: ₹30,000.00 - ₹40,000.00 per month
Ability to commute/relocate:
- Baddi, Himachal Pradesh: Reliably commute or planning to relocate before starting work (Required)
Work Location: In person
