Quality Assurance Executive

Job Summary

• Management of review of Analytical method validations, Analytical Method Transfers, Analytical method verifications, cleaning method validations, Laboratory personnel qualifications, Lab Instrument Qualifications/calibrations and working standard qualification protocols and reports, along with handling of quality management system at AR&D and Analytical Test Centre (ATC) laboratories at ARPL.
• Management of review of Master Formulation Records, Batch manufacturing records, Batch packaging records, Trial batch documents, Instrument Qualifications/calibrations records at FR&D.

Job Responsibilities

• Review of Analytical method development data, Analytical method validations, Analytical Method Transfers, Laboratory personnel qualifications, Analytical method verifications, Method life cycle management (MLCM), cleaning method validation protocols and reports, along with review of Management of review of Master Formulation Records, Batch manufacturing records, Batch packaging records, Trial batch documents, Instrument Qualifications/calibrations records.
• Facilitation for timely initiation and closure of Change controls through Trackwise.
• Ensure for the review and completion of the change assessments in QMS Trackwise Change control system.
• Accountable for the review of calibration and Qualification reports for Analytical laboratory instruments.
• Review of working standard Qualification protocol and reports.
• Review of analytical documents generated by AR&D and ATC laboratories.
• Review of various documents generated by FR&D laboratory.
• Responsible for review/verification of analytical data through LIMS.
• Accountable for maintaining the seamless operation of the Quality Systems on daily basis.
• Documentation control: ensuring archival / retrieval and updation of documentation as per procedures defined.
• Accountable for evaluating exhibit stability protocols, as well as the associated analytical data and reports within the AR&D and ATC laboratories.
• Facilitate prompt evaluation and authorization of stability summary reports.
• Responsible for the active involvement in all laboratory investigations at AR&D and ATC laboratories.
• Accountable for the evaluation and endorsement of investigation reports, as well as ensuring their closure within a designated timeframe.
• Participation in Regulatory / Customer / Vendor / Internal and self-inspections.
• To oversee all functions within the Quality Assurance department, encompassing current Good Manufacturing Practices (cGMP), current Good Laboratory Practices (cGLP), as well as the documentation and execution of quality systems within the departmental quality systems.
• Accountable for operating safely while working collaboratively as part of a team to accomplish all objectives.
• Ensure adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Responsabilités inhérentes à l’emploi

Job Requirements

Exigences liées au poste