4-5

QA documentation, SO Ps, CA PA, change control, and compliance. QC leadership, validation, OOS/OOT, audits, and compliance.

Method development & validation for tablets, capsules, creams & ointments. Exposure to US/EU regulatory requirements.

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.Sc/ B.Pharm / M.Pharm. To plan, prepare and review of high quality dossier with support and guidance, assuring technical concurrency and regulatory compliance, meeting agreed upon timeline.

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.

Managing initial clinical trial application submissions in the EU according to the Clinical Trial Regulation and all changes during the life cycle of clinical trials.

Bachelors degree in chemistry, toxicology, product stewardship, industrial hygiene or related discipline required

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