Job Description:Dear Candidate, Greetings from Otsuka..!! We are looking for a candidate with sound experience into Process Validation at Managerial level in our Formulation plant, especially into injectables / parenterals. The brief responsibilities are outlined as follows: To execute and review PV protocols To support Executive in preparation of calendars for yearly activity To review process validation & qualification planner To ensure Material issuance for validations activities To ensure implementation of validation, qualification activities & inform to Department Head about any deviation. To ensure sample withdrawal during process validation. To ensure Observations sheets for process validation are duly filled & signed. To coordinate among various departments for process validation, qualification activities. To conduct trainings after training material is reviewed by Department Head. To conduct new equipment qualification & validation. To conduct all Change Control Note (CCN), Deviations for International Regulatory Affairs (IRA) / Regulatory / Queries / Compliances / Submissions / In-Process Quality Assurance (IPQA) data / Corporate Quality Assurance (CQA) data preparations & submissions after consent with Department Head. To train the personnel of Manufacturing and other departments on various aspects of Good Manufacturing Practice (GMP). To ensure that all Calibrations are performed as per the Calibration Manual.