26 Oct
|
DISHMAN CARBOGEN AMCIS
|
Ahmedabad
26 Oct
DISHMAN CARBOGEN AMCIS
Ahmedabad
Role & responsibilities
- Plan and execute analytical method validation, verification, and method transfer activities in compliance with regulatory guidelines.
- Independently handle stability studies, data interpretation, and analytical trending.
- Operate and troubleshoot advanced analytical instruments including HPLC, UPLC, GC, GC-MS, GC-HS, and Dissolution Systems.
- Review analytical data, protocols, reports, and laboratory documentation.
- Lead laboratory investigations related to OOS, OOT, deviations, and CAPA implementation.
- Ensure GMP, GLP, and Data Integrity compliance across analytical activities.
- Coordinate with QA, Production, Regulatory Affairs, and cross-functional teams to ensure timely project completion.
- Drive continuous improvement initiatives and support regulatory inspections/audits.
Preferred candidate profile
- 5-8 years of experience in Analytical Method Validation within API/Pharmaceutical industries.
- Robust expertise in Method Validation, Method Transfer, Stability Studies, and Data Integrity compliance.
- Hands-on experience with HPLC, UPLC, GC, GC-MS, GC-HS, and Dissolution Systems.
- Exposure to laboratory investigations, CAPA, regulatory audits, and compliance activities.
- Strong analytical, communication, and stakeholder management skills.
📌 Executive / Senior Executive - QC Analytical Method Validation (AMV) (Ahmedabad)
🏢 DISHMAN CARBOGEN AMCIS
📍 Ahmedabad