Akums Drugs & Pharmaceuticals Limited is an internationally recognised and one of the leading contract manufacturing Pharmaceuticals Company. Akums has rapidly emerged as the premier integrated pharmaceutical company in India. Its business focus is on manufacturing & marketing of pharmaceuticals products in country along with serving clients across the globe.
Akums Drugs & Pharmaceuticals Job vacancy
- Qualification: MS/M.Sc(Science) in Chemistry, M.Pharma in Pharmacy
- Experience : 10-20+years
- Role: Manager – Analytical Method Validation
- Job Location: Haridwar
- No.of Openings: 01
Interested can share their profile to [email protected]
Job description
- Overall responsible for the Validation of Analytical Methods for both Drug Substances & Drug Products.
- To lead a team of SMEs for Method Development and Method Validation.
- To ensure all time functioning of all Analytical instruments and to get maximum output.
- To ensure timely calibration of all Analytical instruments as per respective SOPs.
- To guide and coach a team of Analysts for Method Development and Method Validation of Drug Products for various tests.
- To develop Analytical Methods for Cleaning Validation Studies and No Cross-contamination studies.
- To work coordinate closely with the Plant team for successful Technology transfer of Analytical Methods.
- To ensure preparation, review and approval of SOPs, Protocols and Reports.
- To ensure Good Documentation Practices and Archival of Data and Documents in line with Regulatory requirements and expectations.
- To approve calibration planner for all Analytical instruments.
- To ensure timely availability of reference standards and impurities required for Method Development and Validation.
- To ensure the availability of columns, reagents and chemicals required for AMV.
Desirables
- Must have worked on the Development and Validation of Analytical Methods for both Drug Substances & Drug Products.
- Must have hands-on experience in Operation and Calibration of HPLC, Head Space GC and Dissolution.
- Must have worked at least at the level of Manager AMV and must have transferred methods from ARD to QC [Manufacturing Site]
- Must have a very good knowledge of ICH guidelines for Analytical Method Development and Validation.
