Job Description

Job Description

Job Responsibilities: -

·        To Review The Executed/Intended BMR, BPR, Protocol, Batch Formula, Batch Summary, Flowchart And Other In-process Data.

·        To Review The Analytical Results W.r.t. Specifications & Compliance.

·        To Review Process Optimization, Pre-Exhibit, Exhibit And Process Validation Protocol & Reports Of Drug Product.

·        To Prepare Certificate Of Analysis (COA) Of Raw Material, Packaging Material, In Process, Finish Product, Innovator.

·        To Prepare And Review Other Dossier Filling Documents Like- Dissolution Profile, Retesting Schedule,

·        Reconciliation Sheet, Vendor Address List, Residual Solvents Calculation And Blend Uniformity Summary Etc.

·        Preparation And Review Of Annual Report Summary For ANDAs.

·        To Prepare And Review Risk Assessment Of Elemental Impurity For ANDA, EU And Canada.

·        To Prepare And Review Risk Assessment Of Mutagenic Impurity For ANDA, EU And Canada.

·        Regulatory / CGMP : To Maintain The Compliance Of Quality System In The Department.

Role: Pharma QA ,QC Executive

Industry Type: Pharmaceutical & Life Sciences

Functional Area: Research & Development

Employment Type: Full Time, Permanent

Role Category: Pharmaceutical & Biotechnology

Job Detail