Job Responsibilities
- Perform analytical method development, method validation and query response for the finished product.
- Prepare analytical method development reports, CDP and COA (Certificate of Analysis)
- Perform and review analysis of In-process sample/Finished goods/ Stability samples and related documentation as per cGMP requirement.
- Monitoring general laboratory and its maintenance activity as applicable.
- Responsible for performing routine analysis and stability analysis of the finished product for assay, CU, related substances, dissolution and residual solvent etc.
- Prepare draft STP.
- Review of analytical data, calibration data and qualification data
- Responsible for troubleshooting and maintenance of HPLC, GC, UV/Visible and spectrophotometer etc.
- Calibration of analytical instruments like Analytical Balance, pH meter, UV spectrophotometer, KF Potentiometer, Karl Fischer as per the schedule.
- Following in house systems and procedures to ensure cGMP practices and regulatory requirements.
- Maintenance of reference standard, working standards and their standardization.
- Co-ordinating the activities in Chemical and Instrumentation.
- Handling of Troubleshooting.
- To update instrument log book entries
Desired Skills
- Must have experience in formulation testing in reputed pharma organizations.
- Handling of instruments like HPLC, GC, UV, UPLC, Dissolution tester, KF, FTIR.
- Strong knowledge of Microsoft Word/Excel.PPT.
- Good Communication and problem solving skills.
- Should be assertive, proactive and self-driven.
- Should be willing to work in a dynamic work environment.
Pedigree
B. Sc (Chemistry), M.Sc (Chemistry) with 1-3 years of relevant work experience.
