Quality Assurance Officer
6 months ago
Preparation of Validation Master Plan and departmental SOPs.
- preparation of analytical method validation/ Verification and analytical method transfer protocol as per USP and ICH guideline.
- Issuance of Specification, standard testing procedure,SOP and formats.
- Handling Of QMS elements E.g.Change control, Deviation,CAPA,OOS,OOC,Laboratory Incidents and complaints.
- Audit Trail Review of laboratory software's like Like HPLC,GC Software Etc.
- Conduct The Self inspection,report and discuss the findings with top management independently.
- Handling of regulatory queries related to licensing and dossiers.
- Training to entra and enter departmental staff.
- Quality Risk Management AS PER ICHQ9.
- Independently handling of inspections at site e.g.FDA, NABL and customer inspections.
- Preparation of Compliance report to inspections.
**Salary**: ₹18,000.00 - ₹25,000.00 per month
Schedule:
- Morning shift
Ability to commute/relocate:
- panchkula, haryana: Reliably commute or planning to relocate before starting work (required)
**Education**:
- Bachelor's (preferred)
**Experience**:
- total work: 3 years (preferred)
Work Location: In person
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