Head of Quality

4 days ago


Ahmedabad, India PI Health Sciences Ltd Full time

Job Title:Head – Quality (India Operations: R&D & Manufacturing)Location: Panoli, Gujarat, IndiaPosition SummaryThe Head – Quality will provide end-to-end leadership of the Quality function across Discovery & Process Research R&D centres and the Manufacturing Plants. The role is accountable for ensuring that all R&D and manufacturing operations meet global regulatory requirements and that a culture of Quality and continuous improvement is embedded throughout the organisation.Key ResponsibilitiesStrategic & LeadershipDefine and implement the Quality strategy for India Operations covering R&D (Discovery Chemistry, Process R&D) and the Manufacturing Plant .Act as the primary Quality representative in the India Leadership Team and partner with Global QA to align corporate and site quality standards.Drive a culture of quality ownership, data integrity and right-first-time execution across R&D and manufacturing.Quality Systems & Regulatory ComplianceEstablish and maintain a robust Quality Management System (QMS) to comply with ICH, USFDA, EMA, MHRA, OECD-GLP and cGMP requirements.Lead and oversee GMP/GLP compliance across laboratories and manufacturing operations.Plan and manage internal audits, customer audits and regulatory inspections , ensuring timely closure of observations and effective CAPA management.Oversee change control, deviation management, OOS/OOT investigations, and document control for both R&D and manufacturing units.R&D & Manufacturing InterfaceProvide Quality oversight for tech


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