Deputy Manager-QA

To ensure that all the computerized systems meeting the 21 CFR part11, EU ANNEX 11and GAMP5 guidelines requirements. Involvement during the computerized system validations and there by reviewing the validation documents. Coordinating with corporate QeC & IT teams to implement best practices with ITC Governance initiatives and corporate policies. Providing support in periodic assessments to ensure the compliance of defined IT related SOP‘s and procedures of computerized systems. Performing investigations related to computerized systems, there by identifying the root cause and making sure that adequate CAPA is in place. Responsible for review of IT supplier assessment and ensure that all the software’s are in compliance. Involving and providing support during customer and regulatory audits. Responsible for handling Data Integrity (DI) initiatives at site. Responsible to perform internal self & DI audits for IT related systems. To conduct trainings on computer system validation, 21 CFR part11, EU ANNEX 11 and GAMP5 guidelines for site teams. Responsible for review of SOP’s related to IT systems. Responsible for review of change controls and deviations related to IT systems. Coordinates with all functional departments to do uninterrupted GMP and 21 CFR Part 11 implementations and report the concerns/status on day today basis to reporting manager. In my absence, responsible manager shall take care of my responsibilities. Any other works allotted by the Head – Quality / QA / Designee on day to day basis.