Quality Assurance Officer

3 weeks ago


Nashik, India Deltafinochem Pvt. Ltd. Full time

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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