Associate - Analytical Quality Assurance (Api

4 days ago

Mysore, India Ls Hireman consulting Pvt Ltd Full time

**Analytical Quality Assurance**:
Associate / Sr. Associate -MSc Chemistry with 04 to 07 Years’ Experience

CTC: Upto 6 Lakh
- Review of analytical data generated at Quality control laboratory different analytical testing
- Review of method development and validation/verification protocol and report dossier
- Review of method transfer protocol and report
- Review of batch release analytical 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 like UV, TOC, Malvern, FTIR etc.
- Review of analyst qualification protocol and report
- Review of daily calibration data generated in laboratory
- Internal audit of laboratory
- Review of Quality control SOPs
- Handling of regulatory inspections as an Analytical SME
- Participation in risk assessment for analytical activities and enforce SOPs
- Handling of QMS documentation like change control, lab incidents, OOS, OOT, investigations.
- 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.
- 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.
- Review of analytical specifications using current pharmacopoeias and reviewing existing analytical specifications.
- Evaluation of instrument calibration procedures and data generated during calibration

**Salary**: ₹500,000.00 - ₹600,000.00 per year

Ability to commute/relocate:

- Mysore, Karnataka: Reliably commute or planning to relocate before starting work (required)

**Education**:

- Master's (preferred)

**Experience**:

- total work: 3 years (preferred)

Work Location: In person

**Speak with the employer**
+91 9511235506

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