Sterile Manufacturing operations

• Handle the whole production related activities like as Production Planning and manpower handling.• Participation in Internal Audit as an Auditor, for Quality department.• Ensuring the regulatory and Internal Audit Compliance.• Handle the CAPA, Change control, Event and incident.• Qualification activities for filling machine, Manufacturing tank and related equipments.• To give the SOP training for Staff and worker related to aseptic area practices as per training calendar.• Handle the all activity from machine receive from supplier to machine installation and handover the production.• Training on documentation, Systems and Process to Production Staff.• Planning of Media fill on new installed equipment.• Preparation of Area start up protocol, Prerequisite, qualification Protocol, Filling machine Qualification Protocol.• Gap analysis and improvement in the existing system and process.• Planning of Media fill on new installed equipment.• Media fill plan as per media fill matrix. • Handle the whole production related activities like as Production Planning and manpower handling.

Handle the whole production related activities like as Production manufacturing of ampoule filling lines from start of manufacturing to final filling activity for the regulatory market. To impart the training to personnel regarding global quality regulatory program quality alerts, clean room behaviors, QRM etc.. Performing investigation for different kinds of incidents related to compounding, filling. Proposal of suitable CAPAs and effective implementation. Ensuring the regulatory and Internal Audit Compliance. Handle the QMS related activity like CAPA, Change control, Event and incident, risk assessment. Manpower skills development & training. Gap analysis and improvement in the existing system and process. To ensure discipline on shop floor and team building spirit among team member

Aurobindo Pharma Ltd is well established Pharma Company in India. Aurobindo Pharma Ltd is approved by Regulatory Authorization of USFDA, MHRA, ANVISA, ANVIMA, TGA, WHO etc; Domain ExposureProduction of small volume Dry and lyophilized parenterals products in vial

Unimark Remedies Limited is well established Pharma Company in India. Unimark Remedies Limited is approved by Regulatory Authorization of USFDA, WHO. Formulation plant for dry parenterals especially carbapenem group (meropenem, imipenem with cilastatin) products is under commissioning for production.; Domain ExposureCoordinate with project group for day to day commissioning activity for the Production (Formulation) of Small Volume dry Parenteral in, vials in injectable section

Claris Life sciences Limited is approved by Regulatory Authorization like USFDA, WHO, MHRA, TGA, ANVISA, ANVIMA, MCC.; Domain ExpertiseProduction (Formulation) of Small Volume liquid Parenteral .

U.K, M.C.A-U.K, M.C.C-South Africa, M.C.A.Z. - Zimbabwe, CIS Country, W.H.O .Approved Plant at Kandla.Domain ExpertiseProduction (Formulation) of Small Volume liquid Parenteral in Ampoules and vials in injectable section; Chemist (Production, Formulation) Audit FacedUSFDA (Regulatory of US) MHRA (Regulatory of UK)TGA (Regulatory of Australia)