M.Pharm

Minimum qualification requirement is to have a Bachelors or Masters degree in a health related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health.

To procure raw materials, packaging materials and Reference product in consultation with packaging / purchase department.

To design and conduct experiments for preformulation, formulation optimization of Microsphere and long acting complex non oral dosage form based on QbD approach.

Manage regulatory audits, customer inspections, and internal audits; ensure effective handling of OOS/OOT, deviations, CAPA, and change control activities.

Experience in Blister Line, Bottle Line, QMS, Documentations. Can able to Manage shift operation Independently.

He must be aware of good documentation practices and aseptic behavior. Person should have hands on experience in microbiological activities such as Sterility, BET, Antibiotic assay, MLT and Culture Handling.

Any M.Pharmacy / MSc with 6 to 10 Years or B.Pharmacy with 8 to 12 Years of relevant Experience in Manufacturing Downstream injectables with Strong people management experience in a regulated manufacturing operations environment.

Dossier Preparation in CTD/ACTD/eCTD/National format. Must have Parenteral and partially OSD dosage forms exposure.

Adequate understanding on respective authority guidance and filing of new product and post approval changes. Review of documents related to product registration and dossier submission leading to faster approval