Manager - 2 Engineering QMS

Job Description

He is authorized to sign (as a doer / reviewer / verifier) [May not be limited to]: Engineering GMP Documents. Qualification Documents. Break down/Preventive maintenance report. QMS documents review and closing. Any other documents related to QMS. Ensure that Engineering QMS Documents (Deviation, CAPA CC) are closed within timeline. Implementation of CAPA within time limit. Tracking of department QMS documents ((Deviation, CAPA CC) Preparation of GMP and QMS record. Preparation of Internal and external audit Compliance report. Participate in engineering investigation. To impart required training to concern persons. Participate in monthly Quality Review board meetings and update status of Eng. CAPA, Deviation and Change control. Coordination with cross functional department for closing of QMS documents. To ensure that department biannual due SOPs are revised before due date. To update the status of issued Qualification protocol on monthly basis. To ensure timely closing of FMS and EDMS issued forms. Ensure timely completion of SOPs training. Tracking and Handling of training related activity. Ensure timely retrieval of SOP from QA and maintain the SOP Index. Documents are maintain as per SOP.