Apprentice Ahmedabad, Gujarat, India
- Extensive literature search related to the products assigned.
- Formulation development, process development, and manufacture of GMP batches.
- Preparation of technical documents like development reports, manufacturing docs, technology transfer documents.
- Ensuring good documentation practices.
- Manufacture of batches by GMP norms to meet product filling requirements for various markets such as but not limited to US, Europe, Australia.
- Ensuring the completion of project within agreed timelines, cost, and specs.
- Extending cooperation to support team for smooth functioning of project.
- Overview the calibration activity in FD lab.
M.Pharm in Pharmaceutics
Executive-QA Ahmedabad, Gujarat, India
Review of protocols and reports related to qualification of equipment, instruments, utilities at the site.
-Monitoring of qualification activities of equipment, instrument and various utilities and to ensure their appropriate compliance to defined procedures.
-Compliance monitoring of calibration activity and preventive maintenance activity.
-Review of batch manufacturing and packaging related documents.
– Execution of In-process Quality Assurance activities (shop floor QA activities) involving line clearance, in-process sampling, retention sampling, sampling of swab sample during cleaning verification for batch manufacturing and packaging.
-Review of raw data for analytical testing.
– Knowledge of QMS – change control, investigation of deviation / OOS.