Analytical Quality Assurance
2 weeks ago
**Roles and Responsibilities**
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.
- Role:_QA / QC Analyst
- Salary:_ Not Disclosed by Recruiter
- Industry:_Pharmaceutical & Life Sciences
- Functional Area_Quality Assurance
- Role Category_Production & Manufacturing
- Employment Type:_Full Time, Permanent
- Key Skills
- GC-MSQCanalytical methodAnalytical Method ValidationGCQuality AssuranceMethod TransferHPLCAnalytical TestingQuality Control
Education
- PG:_MS/M.Sc(Science) in Bio-Chemistry, Biology, Chemistry
**Company Profile**:
Avani Consulting
- Leading Recruitment Consulting Company in India.
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