Company: Akums Drugs & Pharmaceuticals Ltd
Post: Sr. executive Analytical Method Development
Experience: 8-10yrs
Qualification: Relevant
Location: Navi Mumbai
Roles and Responsibilities
1. To perform a complete analysis of Routine and stability samples (Formulations, APIs, and Excipients)
2. To perform calibration of all analytical instruments like Balances, HPLC, GC and Dissolution etc.
3. To develop Analytical methods for Assay, RS and Dissolution by UPLC & HPLC etc.
4. To review all DMF (API and Excipients tech pack).
5. To Prepare Protocols, Specifications, Standard Test Procedures, Lab STP, VSTP and Method development reports, etc.
6. To Prepare Standard operating procedures and other analytical technical documents
7. To Maintain GLP documents like Instrument logbooks, LNBs, Daily calibration logbooks, routine responsibilities, etc.
8. To perform analytical method pre-validation for HPLC, UV, GC, etc. for US, EU, JAPAN, CHINA, ROW, DCGI and other regulatory projects.
9. To perform analytical method validation and analytical methods transfer for HPLC, UPLC/GC etc. as per requirement.
10. To guide junior associates for routine analysis of HPLC and UPLC etc.
11. Co-ordinate with service engineers / internal engineer team for PM and calibration of all ARD instruments and equipment
12. To prepare ROA/COA for routine, Stability and VQ analysis
13. To prepare, update and review the calibration schedule and all instruments history cards
14. To maintain the record for breakdowns of instruments and equipment
To maintain a record of external calibration of equipment and instrument.
Desired Candidate Profile
Qualification required M.Pharma
Experience in R&D: About 8 to 10 years
The candidate should be a Pharma background
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