40 Openings At Amneal Pharmaceuticals Recruitment for ITI,B.Sc,Diploma,B.Pharm,M.Sc,M.Pharm

Desired Profile:

• To observe & follow all rules and regulations of the Sterile Manufacturing (Injectable/Parenteral Unit) department.
• Must be from Parenteral background & exposure to filling process is desirable.
• To be aware and responsible for achieving quality objective and fulfilling the requirements of applicable quality procedures.
• Sound technical knowledge of Aseptic area & Controlled area related activities.
• Technical exposure and expertise on filling & Autoclave machine.
• Knowledge of Regulatory guidelines and exposure of USFDA audits.
• Knowledge of Quality Management System (QMS) i.e. change control, Deviation, CAPA, and documentation in manufacturing area of injectable.
• Expertise in batch manufacturing and preparation related activities.
• Knowledge of equipment validation and qualifications in injectable.
• Preparation & review of BMR-BPR
• Preferred Exposure for Ophthalmic line: Three piece sterile eye drop filling machine operation (Groninger), Nanomill Operation, autoclave (Fedegari) Manufacturing and Filtration vessel operation, CIP and SIP processing
• Knowledge of packing area operation and visual inspection

Candidate with good communication & interpersonal skills, computer knowledge, exposure to cGMP/ GLP and understanding of regulatory requirement will be preferred.

Note : Candidate should have 02 to 07 years of relevant experience in USFDA regulatory approved pharmaceuticals (Preferred 21 CFR compliance) organization.

Area: Aseptic & Controlled area operation (Filling, Sealing, filtration, intervention, Production QMS, Autoclave, Batch Manufacturing, terminal sterilization etc.)

Line: Ophthalmic, PFS, Lyo and Vial

Machine Exposure: Three piece sterile eye drop machine (Groninger), nenomil, isolator, Trucking, Bosch, fedegree & Optima