Manager

Job Description

• Review and Approval of master documents like SOPs, specification, STPs, OPML, batch manufacturing, batch packing records and stability protocol.
• Review and Approval of quality system documents like change control, market complaints, deviation, OOS, OOT, CAPA etc. in QAMS.
• Review and participation in investigation of deviations, market complaints, OOS/OOT, incidents etc.
• Handling of recall and return goods, Field Alert Report, CAPA and participate in self inspection.
• Review of validation protocols, annual product quality review of drug product
• Perform the Quality risk assessment
• Preparation and review of hold time study protocols and reports.
• Review and maintain site quality management details
• Release or rejection of finished products in SAP for market distribution.
• Approval of various documents in SAP system
• To check the maintenance of the department, premises and equipment/instrument

Work Experience

10-12 years

Education

Competencies