2-3

To be aware and responsible for achieving quality objective and fulfilling the requirements of applicable quality procedures.

B.Sc./ M.Sc./ B.Pharm / M.Pharm. Manufacturing / Packing, Quality Control, Quality Assurance. Exposure to OSD Manufacturing operations like Granulation, Compression, Coating, Pellet coating, Capsule filling, Primary Packing and Secondary Packing. Working in USFDA Plant.

M.Pharm, B.Pharm, M.Sc, B.Sc, ITI, Diploma; Experience Into Analytical Validation. Finished Goods. Raw Material. Stability & CLP

M.Pharm. Exposure in EU/ US/ UK/ ROW market. Formulation patent exposure. Strong communication skills, Problem-Solving, & Adaptability.

Preparing eCRF specifications, Edit check specification and other study specific set up documents.

Handling of production machines such as BQS, Coating, Granulation. Bottle line packing machine primary and secondary.

To support for commercial troubleshooting/remediation/Market complaints for Non-Oral manufacturing sites. To support for timely investigation/execution and to resume commercial manufacturing and to meet market/ sales requirement.

Dissolution apparatus, GC, IR and AAS and Documentation related to QMS. To review respective GMP Documents of QC department such as analytical / worksheet of In Process and Finished Product.

M.Pharm/B.Pharm/M.Sc/B.Sc Review of BMR/BPR and process validation reports, in process testing, sampling and line clearance, Media Fill. Emcure