QA

B.Pharma, B.Sc., M.Sc.  Granulation, Compression, Coating, Continuous coater, Capsulation, Press-fit, Inspection. Blister Packing, Bottle Packing, Bulk Packing. Exhibit/IP/FP, Hold Time, Stability, Vendor Qualification, Method Validation and GLP, RM, PM, VQ, Sample Management

Manufacturing, filtration, filling, Lyophilization, sealing, and pre- and post-manufacturing activities. Planning and execution of batch manufacturing activities, filling activities, lyophilization, sealing activities, and filter integrity. Monitoring NVPC and trending.

Stallion Laboratories incorporated in 1988 as an integrated private sector Pharmaceutical Formulation Manufacturer, has acquired an unmatched record of managing niche product in formulations with a WHO GMP approved production facility and GLP qualified stringent quality control.

Conduct QC testing on raw materials, packaging, stability, in-process, and finished products. Capable of Handling Instrument like HPLC, GC,KF, IR,UV instrument. To review analytical data & handling of QMS i.e. Deviations, 00S, 00T, Laboratory incidences, OOC, CAPA and Effectiveness of CAPA.

Monitor and supervise production process to ensure compliance with SOP and cGMP. Maintain documentation as per regulatory authorities requirement like change control, deviations. Highlight technical problems and take corrective actions.

interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. Lead submission for annual reports, facility registrations, facility renewals, and product renewals. Interact with authors, reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions.

Exposure of Equipment and Utility Qualifications. Good Knowledge of Process Validation, Cleaning Validation. Management of QM5. Exposure of Stability and Artwork Management Analytical QA Handling of OOS, Risk Assessment, Self Inspection, APQR

Review of Literature and patents and preparation of Pre-product development strategy. Execution of experimental work and reporting of observations. Compilation of pre-formulation data on the drugs and excipients used in the formulations.