5.0 - 9.0 years

0 Lacs

maharashtra, tarapur

On-site

You will be responsible for supervising and guiding the IPQA team to conduct real-time monitoring during manufacturing and packing processes. Your role will involve ensuring compliance with BMR/BPR review and approvals at each stage, as well as overseeing line clearance before manufacturing and packaging activities. It will be essential to monitor critical process parameters, in-process checks, and control sampling activities including IPC, stability, validation, etc. You will be expected to ensure timely review and approval of executed batch records and logbooks, review and ensure compliance of standard operating procedures (SOPs), and maintain and control GMP documentation related to IPQA activities. Leading or supporting investigations for deviations, OOS, OOT, and market complaints, conducting root cause analysis, supporting risk assessments, and ensuring timely closure of CAPA, deviation reports, and change controls will be part of your responsibilities. In addition, you will be required to train manufacturing and QA staff on GMP, GDP, and IPQA procedures and ensure readiness for regulatory and customer audits. Your main objective will be to lead the IPQA team effectively, ensuring in-process quality assurance activities comply with cGMP, regulatory, and internal quality standards across all manufacturing and packaging operations. Your role will play a crucial part in real-time monitoring, process compliance, and product quality assurance during manufacturing.,

Posted 1 month ago

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