- 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

Graduation in Pharmacy

Competencies

CollaborationCustomer CentricityDeveloping TalentInnovation & CreativityProcess ExcellenceResult OrientationStakeholder ManagementStrategic Agility

📌 Manager (India)
🏢 LUPIN
📍 India