Group Lead - Manufacturing Assurance

Overall responsible for day to day monitoring and compliance of Bulk manufacturing and FFP operations with cGMP and approved site procedures at two SHIPL locations based in Hyderabad. Review and approval of quality system documents like deviations, change controls and CAPA Review and approval of MFR, MMR, SOPs, RSTs and protocols/reports for process validation and study designs etc. Lead failure investigation and root cause analysis Review and approval of project master plan, URS, DQ, IQ, OQ, Technology transfer, protocols/reports related to projects at SHIPL site Defining, implementing, managing and controlling the quality system in order to ensure quality of the product manufactured in compliance with established procedures Developing procedures to align with Global quality directives, Operational quality standards and guidance Ensure that adequate controls are established for starting materials, and bulk products. Evaluation of change control in PHENIX as a Site Quality Manager To approve executed Batch manufacturing record (BMR) Tracking and reporting of quality performance indicators that measure quality and compliance on a routine basis To ensure the product compliance with registered dossier Participation and support in customer complaints and product recall Review and approval of technology transfer documents for new projects and review and approval of layouts and other documents To harmonize the operational SOPs across all the suites Support for CTD review and submission to the regulatory To involve and ensure to meet the site quality plan objectives and KPI Quality metrics of Bulk manufacturing at Medchal site.

To participate in global / corporate initiatives To review and approve the risk assessment (pre/post) wherever applicable To apply the QRM (Quality Risk Management) to any risk related to quality and GxP compliance at shopfloor To ensure that a process and systems are implemented to identify, analyse, evaluate, control, communicate and review potential or identified risks related to quality and GxP compliance in line with site policies / procedures To provide the inputs to Risk register and ensure the effectiveness of CAPA to reduce the risk to acceptable quality level Responsible for identification, analysis, evaluation & documenting the risk and implementation of appropriate mitigation plan. Accountable to ensure that risk is logged, and risk assessment is approved Support the QRM activities by ensuring the availability of required resources, approval of CAPEX/OPEX (if any) To issue the Quality alert (RQN) Participation in self-inspection / internal audit / supplier audits Participating in the project meetings and to ensure the project gate criteria Maintain a safe and healthy workplace environment. Support safety audits and ensure timely closure of any safety related action plans.

To report unsafe conditions and incidents to HSE.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.