Role & responsibilities
I. Unit Strategy - Strategic Capability Plan
Develop and secure approval of the Unit Annual Strategic Capability Plan for the Unit and drive its implementation within allocated budget and resources.
Contribute to Site Strategic Capability Plan development & implementation.
II. Integrated Quality & Product Safety - QMS, cGMP & Product Regulatory Compliance: Ensure cGMP compliance of the unit by building, assessing and tracking the systems and controls at unit to meet regulatory and customer requirements
Establish, implement, monitor & review a system of proper verification and exercise of due diligence through periodic institutionalized reviews / audits and Gemba walks with the Unit Teams to ensure that:
all cGMP, Product Regulatory & Customer requirements are met for the Unit;
batches are produced in controlled manner in accordance with approved dossiers and requirements of Marketing Authorization ensuring that the product is protected, efficacious and meets the quality standards;




QMS is implemented & continually improved for the Unit in collaboration with the Site/Unit QA&QC; Teams, with a focus on:
TRUST - a Strategic Quality Culture Initiative;
Ontime closure of investigations (Complaints, Deviation and valid OOS);
RFT: Improve RFT % (# of batches RFT without non-conformances - Valid OOS);
Trend of repetitive Deviations and CAPA effectiveness (% No Repeat Deviations);
Escalate any gaps to the Senior Management and drive identification, development, implementation and closure of CAPAs.
Ensure ALL TIME READINESS for audits.
Ensure integrity of documentation & compliance to cGMP for continuous improvements in quality and systems
Monitor the quality score of unit and all related dimensions to meet the set standards
Ensure the implementation of quality systems policies and generate action plans during Quality Management Review.
Monitor the quality risk management process to ensure that it is defined, deployed and reviewed as per laid down procedures

📌 Unit Head (Pune)
🏢 Cipla
📍 Pune