Analytical Quality Assurance @ Avani consulting

Job Description

Greetings from Avani consulting.!

We are hiring for the Analytical Quality Assurance profile for API Manufacturing company in Mysore.

Job description:

• 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. will be added advantage
• Candidate should possess managerial skills and team building capability.

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Thanks & Regards

Jyotsna

HR Recruiter

Avani Consulting

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Keyskills:   qms sop lims hplc