Sr. Manager - Sterile Production Pharmaceutical

Role & responsibilities

• To ensure training and good clean room practices according to the regulatory guidance.
• Coordination for manufacturing of Injectable formulation technology and support for manufacturing of clinical supplies.
• To execute, monitor, plan of qualification activities like URS, FAT, DQ, IQ, OQ, PQ of equipment/Instrument for small volume parenteral.
• To participate for sterility assurance qualification such as media fill, leak test, steam sterilization, terminal sterilization etc.
• Should have exposure of Regulatory Audits like EU GMP, USFDA etc.

• Candidates Specially preferred from reputed pharma. background.