Ing. Shruti Prafulla Anikhindi

• Perform review of the configuration management of the systems against its baseline; documentation of the configuration review report • Review of the incidents, problems, change request, non-conformities and deviations to evaluate the overall validated status of the system(mainly for GxP IT systems) and there by assess their compliance according to the GAMP 5 guidelines • Providing solutions to the stakeholders from compliance perspective and thereby providing the value add to the stakeholder

• Review and approve key deliverables as defined within the Master Validation Plan [MVP] in order to assess their compliance with applicable Pharmaceutical Regulatory bodies such as CFR 21 Part 11 and GSK QMS. • Review of Master Configuration Item List [MCIL] and performing Configuration management audits for GxP Applications • Conduct Internal Audits for SDLC Phases and for Regulatory Compliance adherence per customer QMS.