Production Specialist - Sterile Operations / Aseptic Manufacturing

Sterile / Aseptic Drug Product manufacturing (aseptic compounding/ formulation, filling), Vial and PFS filling machine operation experience , expertise in Lyophization unit process . Experience in eBPR /MES based paper less manufacturing , Experience in managing plant operations as per USFDA and EU / MHRA requirements.

Responsible for production of sterile operations( like Filling , formulations , Lyophilization) as per established cGMP procedure and Safety norms followed in Highly regulated market( USFDA, EU and MHRA).

working experience on Isolators and filling machine for vial , Lyophilizer(telstar, IMA,) and Syringes (OEM like Sterline , B&S,)

Work experience on MES of Werum( pass-X). Hands On experience in aseptic manufacturing of Biological drug product .

Experience of working in lean manufacturing environment , should be experience of Lean daily managements concepts like manager model area , 5S concept and Kiazen etc.