This position is responsible for performing routine and complex analytical testing and analyses of pharmaceutical finished products or raw materials, method transfer and verification.
- Prioritize, schedule and plan daily work in order to maintain efficient workflow to assure completion of scheduled tasks and to meet established due dates.
- Ensure that equipment is maintained in good order, perform calibrations and qualifications as required.
- With limited supervision, prepare study protocols, reports, forms and SOP’s.
- Perform routine and more complex analysis/testing of pharmaceutical and biopharmaceuticalfinished products and raw materials.
- Prepare and standardize Test solutions, Standard solutions and Volumetric solutions.
- Execute and perform testing as per methods, following the company’s Standard Operating Procedures, Deviations and Change Control programs and cGMP guidelines.
- Ensure that work order documentation is complete in every aspect and all results are entered into the electronic Laboratory Information System or the Client’s Certificate of Analysis before submission to the QA reviewer.
- Prepare and assist in preparation of Work Forms as per test methods.
- Record findings in standardized format, keeping all records and analyst notebook in good order.
- Ability to execute method verifications, validations, transfers based on signed protocols.
- In case of testing failure, immediately report to the Department Manager before proceeding any further with the test. Assist in the failure investigations as instructed. Do not discard any solutions or glassware that was used during testing.
- Assist in the resolution of routine, as well as non-routine technical problems.