Analytical Quality Assurance
2 weeks ago
Review of analytical data generated during at Quality control laboratory different analytical testing
- Review of batch release documentation
- Review of analytical protocols for analytical method validation, method transfer and process validation
- Review of analytical data release docket
- Review audit trails in Empower software and other standalone instruments
- Review of daily calibration data generated at laboratory
- Internal audit of laboratory
- Preparation of protocols for analytical activities
- Review of Quality control SOPs
- Exposure to regulatory inspections like USFDA, EDQM
- Conduct risk assessment for analytical activities and enforce SOPs
- Knowledge and hands on experience on QMS documentation like change control, lab incidents, OOS, OOT, investigations.
- Preparation and review of laboratory incidents, OOS and OOT reports.
- Awareness of 21 CFR part 11 requirements including User Management Policies, audit trail review etc.
- Review of laboratory computer system validations as per GAMP guideline.
- Hands on experience in sophisticated instruments like HPLC, GC, GC-MS, Malvern, TOC for testing of sample for Purity, impurity etc.
- Review of Instrument Qualification documents in line with regulatory requirements
- Preparation and review of Quality reports, including analytical reports (for raw materials and finished products), Certificates of Analysis (CoA) (for finished products) and stability reports.
- Writing analytical specifications using current pharmacopoeias and reviewing existing analytical specifications.
- Supporting all QC activities for review and timely release of test reports.
- Experience to work on Quality management software like SAP, Track wise, LIMS etc.
Note: Green field facility system development experience will be preferable.
**Salary**: ₹500,000.00 - ₹800,000.00 per year
Schedule:
- Day shift
Ability to commute/relocate:
- Mysore, Karnataka: 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-XXXXXXXXXX
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