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.