Carry out the Production Activities as per defined SOPs.
Ensure that the products are manufactured and released as per the cGMP
To ensure compliance to Quality System during manufacturing Process.
Ensure that all the personnel involved in the manufacturing activity and execute their jobs as per cGMP requirements and related SOPs.
Ensuring Batch Formulation, Filtration, Filling, Lyophilization and Sealing activities are carried out in compliance with Standard Operating Procedures, cGMP and Regulatory requirements.
Ensuring that proper Environmental conditions are maintained during production activity.
Ensuring the movement of goods inside the manufacturing area as per the specified SOPs.
Ensuring the activities of Calibration, Performance Verification and Performance Qualification of all the Equipments.
Preparation of Standard Operating Procedures, Standard Operating Instructions and Standard cleaning Instructions.
Issue, Online documentation, completion and Submission of Batch Manufacturing Record.
Involved in the Activities of Media fill Process.
Ensuring the Preventive Maintenance Activities are performed as per the schedules and maintaining the Records.
Performing Periodic Performance Verification of Steam Sterilization Autoclave, Vial Washing Machine, Dry Heat Sterilizer and Lyophilizer
Maintaining the proper Records for all the Processes,Equipments and Activities as per the cGMP requirement.
Execute Validation Activities as per the Schedules.
Involved in the Activities of process validation.
Involved in the Activities of area validation.
Involved in the Activities of equipment validation.
Have faced USFDA, MHRA, TGA audits.
Experience of working with WHO GMP STERILE facility is must, Exposure of working with USFDA, MHRA or any other stringent regulatory authorities will be an added advantage Good knowledge of spoken/written English, basic computing skills like operation of MS Office, emails, good interpersonal skills, team work, presentation skills and analytical abilities
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