Assistant Manager - Production

Job highlights

• Experience in manufacturing roller bottles cultures. Down-stream process steps like concentration of bulk antigen batches.
• Timely update of batch packing records for onward submission to QAD.
• Awareness & Usage of PPE during operations as per requirement & follow the safety.

Responsibilities

• Following cGMP procedures in the company premises
• Compliance to all approved procedures and policies
• Responsible for planning, execution and monitoring of all the production activities in conformation to BMR and online documentation for labelling and packing activities of finished products
• Upstream process of Tissue culture operation
• Experience in manufacturing roller bottles cultures
• Down-stream process steps like concentration of bulk antigen batches
• Revision of SOPs, BMRs, BPRs and all relevant record sheets
• Timely ERP Oracle entries and updates in line with dispatch of finished products
• Timely update of batch packing records for onward submission to QAD
• Actively participate in all kinds of internal and external audits & coordination between all cross functional departments for smooth functioning
• Provide necessary training to all the labelling & packing personnel on cGMP related activities
• Reporting & handling of the quality incidents, deviations, change control, investigations, OOS, OOTs, risk assessments, equipment breakdowns and identification of CAPA and QMS related activities
• Supervision & monitoring of cleaning, housekeeping and documentation
• Procurement & monitoring of materials, creation and closure of process orders in ERP related activities
• Awareness & Usage of PPE during operations as per requirement & follow the safety
• Monitoring and handling of the process related activities and online documentation

Qualifications

• MSc in Biotechnology, Microbiology, Molecular Biology & Biochemistry

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