Description:

This role prepares testing schedules based on priorities, provides hands-on training to new hires, supervises daily testing activities to assure adherence to procedures, cGMP, and SOPs applicable to laboratories, conducts laboratory investigations when needed, participates in cross-functional teams to understand priorities, commits and delivers as committed.

Essential Functions:

Schedules testing/review of raw materials, in-process, finished product, and stability samples, complaint samples, samples from process and cleaning validation activities; assignments shall be in writing and a day in advance. Drives effective and efficient shop floor supervision enforcing compliance to data integrity, SOPs, specifications, methods, USP, and cGMP through real time verifications of records, LNB, log book, chromatograms, sequences, etc. Helps analysts by trouble shooting methods, instrumentation and execution of the tests. Initiates OOS/OOAL investigation, participates in investigation activities, and closes in the books when approved, in a timely manner. Prepares reports of investigation, method transfers, method verification/validation where required. Ensures implementation of CAPA, as identified during the investigations. Ensures timely testing and releases of raw materials, in-process, finished products, stability samples from the lab. Reviews and approves, COA, stability summary reports, investigations, APR trend data, calibrations, qualifications, and other analytical records as needed. Initiates change controls for revisions to any controlled document (SOPs, methods, stability protocol,and specification) applicable to quality laboratory. Reviews changes in compendial methods for applicable products and notifies management of such changes in order to determine appropriate course of action. Has all laboratory personnel complete weekly worksheet, reviews worksheets with respect to schedules, and submits completed worksheets. Involved in day-to-day laboratory testing and helps analysts as and when needed. Reviews method transfer protocols/reports/vendor qualifications reports/USP monograph evaluation reports/training records. Identifies training needs and provides necessary training to the analysts as and when needed.

Additional Responsibilities:

Participates in analysis as and when required for special projects. When required, summarizes data for in-process testing, testing and release of finished products, and stability data for trending. Attends production planning meeting and updates list with delivery dates committed, track delivery dates with respect to committed dates. Submits a list containing weekly samples-in and out.