Quality and Performance Data Officer

3 days ago

Ahmedabad, Gujarat, India PI Health Sciences Ltd Full time
Job Title: Head – Quality (India Operations: R&D & Manufacturing)

The 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.

Define 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 Compliance

Establish 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 Interface

Provide Quality oversight for tech

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