Jr. Manager/Assistant Manager-Upstream Microbial (Biopharmaceuticals)

0 - 5 Years of Experience rupess outline icon

Not disclosed time outline icon

Full Time

Syngene International Limited

time outline icon Bengaluru, Karnataka, India

Posted on 31-05-2023

1 Vacancy

Description

Batch planning in accordance with BMP4 plant occupancy matrix.
Supervise micro batch schedule and shift planning for day-to-day activities.
Represent upstream in internal PRM’s and participate in technical discussions with MSAT and client.
Supervise the upstream activity from inoculum preparation to transfer of harvest to downstream processing.
Raise purchase requisition (PR) for capex items.
GMP compliance in all the manufacturing activities and closure of executed documentation.
Facilitate and monitor those deviations and CAPA are addressed right the first time and maintain required standards of manufacturing quality systems.
Perform GEMBA and safety walks for function specific suites as well as common area of bmp4.
Responsible for handling (receiving, tracking, and providing response) the IPQA observation sheets issued to manufacturing.
Perform review of the upstream related master batch records and executed batch records.
Perform review of protocols (study protocols, equipment qualification protocols etc.). Review the executed protocols and provide adequate support for timely closure of the same.
Collaboratively work with MSAT team to provide input for improvement of products/process.
Work with maintenance and engineering to troubleshoot process problems and identify solutions that reduce the equipment downtime in a cost-effective manner.
Facilitate and monitor that the QUOTIF deliverables related to USP are fulfilled as per the defined timeline.