Dr. Reddys Laboratories is an emerging global pharmaceutical company with proven research capabilities. The company is vertically integrated with a presence across the pharmaceutical value chain. It produces finished dosage forms, active pharmaceutical ingredients and biotechnology products and markets them globally, with focus on India, US, Europe and Russia. The Company conducts research in the areas of cancer, diabetes, cardiovascular, inflammation and bacterial infection.
Post : AQA Reviewer
Job Description
• Review and approval of “Before and After Analysis Checklist” used in HPLC and GC analysis.
• Perform Electronic Sign off 2 for the analysis carried out in HPLC and GC instruments.
• Perform timely review and approval of executed Record of Analysis (ROA’s) as per the approved current version of Specification and Method of Analysis.
• Perform Usage Decision (UD) and Stock Posting in SAP for all Intermediates (including saleable intermediates), Recovered solvents, API, Stability analysis and finished products.
• Review and approval of Analytical documents as per “Batch Analysis and Record of Analysis Review Checklist & Checklist for After Review of Analytical Data”.
• Review and approval of customer complaints, Out of Specification (OOS) investigations and Out of Trend (OOT).
• Support and participate in customer complaint investigations, OOS, OOT, incident investigations.
• Perform and Review Empower Audit Trail as part of document for Individual batch release and weekly audit Trail.
• To perform and review of primary electronic records for Individual batch release and monthly audit trails for all non-chromatographic quality control laboratory Instruments.
• Review of Electronic backup data verification.
• Review of Monograph evolution data.
• Initiation of change control, Co-coordinating for review and approval of change controls related to AQA.
• Review and approval of Analytical Method Validation and Analytical Method Transfer documents.
• Review of status labels and filling the check points in the checklist
• Perform spec check in SAP.
• Review and approval of Analytical Instrument calibration records.
• Initiation of Incidents, review and approval of incidents related to AQA.
• Review and approval of Specification and Method of Analysis.
• Assigning retest period for raw materials and packing materials.
• Ensuring and completing assigned training program in i-learn as per the job role requirement.
• Review and approval of Working standards and Impurity evaluation reports.
• Review of stability reports and performing UD in SAP.
• Participate and support during audits and inspections.
• Perform any other work assigned/instructed by HOD/Designee.
Additional Information
Qualification : MSc Chemistry
Experience : 6 to 10 Years
Location : Hyderabad, Telangana
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 25th June, 2021
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