Quality Assurance Officer
3 weeks ago
Implementation and monitoring of cGMP system in the plant.
- Preparation and review of Standard operating Procedure and formats.
- Issuance of change control, Deviations and OOS.
- Handling of Product complaints and returned goods.
- Co-ordination during investigations for effective closing of OOS, Deviations
- Review and follow ups for implementation of corrective and preventive action (CAPA)
- Product release to the market as per the customer requirement /order process requirement.
- Verification of API and Intermediates dispatch as per order process document and customers requirements.
- Review of validation protocols and reports.
- Review of qualification protocols, reports, calibrations and preventive maintenance schedules.
- Preparation & review of Annual review report of Products.
- Review of Specification & Method of Analysis.
- Online Audits/rounds in production blocks, warehouse, quality control and plant areas.
- Co-ordination during external audits.
- Documentations, Maintenance of External audits and training documents.
- Follow ups for external audit observations.
- Responsible to perform Internal audit/Self
- inspection with maintenance of related documents.
- Responsible to perform vendor or External services audit with maintenance of related documents.
- Review of raw material and packing material vendor documents.
- Review of Batch production records and equipment cleaning records.
- Review of Analytical test reports, raw data, technical information sheet, COA and Product related quality records
- Completion of vendor questionnaire for intermediates/ fine chemical, API and fulfill the customer requirements if any.
- Report to HOD-QA in day to day activities.
**Salary**: ₹20,000.00 - ₹24,000.00 per month
Schedule:
- Day shift
- Rotational shift
Ability to commute/relocate:
- Nashik, Maharashtra: Reliably commute or planning to relocate before starting work (required)
**Education**:
- Bachelor's (preferred)
**Experience**:
- total work: 5 years (preferred)
**Speak with the employer**
+91 8625099936
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