Manager/sr. Manager-ipqa (osd)Job Responsibility
Overall responsible for quality assurance activities on shop floor as per current good manufacturing practices (GMP) and laid down procedures.
Responsible for release and rejection of finish product.
Responsible for review and approval of master documents viz, batch manufacturing record (BMR), batch packaging record (BPR), process validation protocol (PVP), and process validation reports (PVR).
Responsible for review and approval of SOPs, protocols and reports of qualification, hold time study and stability.
Responsible for monitoring and exhibit batches and validation batches.
Responsible for conducting investigation for OOT, OOS, deviation and market complaint for manufacturing site
Responsible for review and approval of deviation, change control OOS, OOT and investigation reports, OOS, OOT and market complaint.
Responsible for review and monitoring of CAPA actions and its effectiveness.
To perform the quality risk management (QRM). Review and approval of QRM Reports.

Keyskills: IPQA QA Inprocess Quality Assurance Inprocess Quality In Process Quality Assurance