About this role
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
Graduation in Pharmacy
## Competencies
Collaboration Customer Centricity Developing Talent Innovation & Creativity Process Excellence Result Orientation Stakeholder Management Strategic Agility