Team member - Sterile Operations (Drug Product Filling)
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Job Description
• Responsible to execute and do the formulation & Filling batch manufacturing activities.
• Responsible to operate and to execute to operate the single use mixer & controllers, and other applicable equipment’s in Formualtion-1 & Formualtion-2 area.
• Responsible to execute and do the component preparation activities.
• Responsible to operate and to execute the Autoclave, Part washer and other related equipment in component wash area.
• Responsible to execute Vial & PFS filling activities.
• To follow Safety guidelines and Safety policies are of sterile operations in projects and operations.
• To follow QMS-Validation-cGMP Compliance in sterile manufacturing facilities.
• To provide the assistance to FFM-2 personnel to maintain all time cGMP readiness in the plant and support the various audits.
• To prepare and to execute the FFM-2 personnel for preparation of SOP (Standard operational procedure), Protocols, Reports, both paper and MES (Manufacturing execution system), and other GMP documents related to sterile operations.
• To be available in shifts to support for the planned activity/batches execution
• Responsible for Filter integrity machine execution
• Preparation of SOP, Study protocols, Study reports and other GMP documents related to sterile operations and C&Q.;
Requirements
Function: Other
Experience Level: Mid-Senior Level