Analytical Quality Assurance

6 days ago

Mysore, India Avani Consulting Full time

**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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