Manager II Downstream Process

Role & responsibilities

Responsibility of Downstream activities in bulk manufacturing facility. To ensure that Downstream batches are carried out as per manufacturing instructions following relevant Process Development description document, MFR, SOPs, BPRs, Protocols etc. and to ensure appropriate documentation in order to maintain cGMP compliance.

Preferred candidate profile

• To understand and follow the safety practices and usage of PPEs in Bulk manufacturing facility and during process.
• Execution of Scale up of Development batches in Bulk manufacturing facility.
• Tracking of inventory of consumables used in manufacturing.
• Ensure Facility monitoring, readiness & maintenance of BM facility.
• Coordination with Engineering department on tracking and completion of preventive maintenance of Downstream Equipments and instruments.
• Following good documentation practices such as online documentation like BPR, equipment log, record sheets, etc. in Downstream process.
• Preparation of Batch production records, SOPs, record sheets and related documents for Downstream related activities in Bulk Manufacturing Facility.
• Review of Batch production records and related documents in Downstream process.
• Responsible for timely closure of Batch production records (BPRs), Protocols and reports related to the Downstream process.
• Coordination with Vendors on equipment and instruments qualification related to the Downstream process.
• Initiation and closure of change controls, deviations related to Bulk Manufacturing area.
• Ensure the timely revision of BPR, SOP and study protocols related to downstream process.
• Responsible for LMS activities as a department training coordinator.
• Involving in internal audits, local DCGI audits and any other regulatory agencies.
• Involving in training on safety related activities and imparted training to pooled staff.