Executive - Upstream

Role & responsibilities

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

Preferred candidate profile

• Preparation of process documents (PCS, MFR, BMR), SOPs, protocols, related documents for upstream activity.
• Hands on experience in operations of seed and production fermenters, continuous centrifuge, homogenizer and continuous involvement and support for commercial batches etc.,
• Involving and supporting in Sun Pharma CQA audits, internal audits ,local DGCI audits CDSCO and any other third party/national &international regulatory agencies.
• Review of batch manufacturing records and related documents in upstream.
• 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, commercial batches and other assigned tasks in Bulk manufacturing facility as per the assigned shift schedule (A,B,C Shift) hours.
• Ensure Facility monitoring, readiness & maintenance of BM facility.
• Coordination with engineering department on tracking and completion of preventive maintenance and calibration of Upstream process Equipment and instruments.
• Following good documentation practices such as online documentation like BMR, equipment log, record sheets, etc. in upstream process.
• Following up with Vendors on equipment and instrument related to upstream process.
• Support for creation of Process Order/material reservation related to SAP transactions and handling of QMS elements activities.
• Support and fulfill for any additional job work activities /other job responsibilities/tasks assigning by reporting manager.