Website Glenmark pharma ltd
Post Name: Executive-ITQA
Job Description
Group Company: Glenmark Pharmaceuticals Limited
Office Location: Chhatrapati Sambhajinagar
Primary Responsibilities:
Proficient in using ValGenesis for managing electronic validation lifecycle and ensuring compliance with FDA 21 CFR Part 11 and GxP standards
Planning and executing Computer System Validation (CSV) activities.
HP-ALM & Documentum for managing electronic validation lifecycle and ensuring compliance with FDA 21 CFR Part 11 and GxP standards.
Performing Computer System Validation (CSV) of Manufacturing Equipment, Utility, Standalone.
Provide advice and support on Validation Activities.
execution of all validation process complies with various worldwide regulations like GAMP 5, 21 CFR Part 11, EU Annexure 11 guidelines. Development and execution of validation documents such as Software Validation Plan (SVP), Regulatory Risk Assessment (RRA), User Requirements Specifications (URS), Design Specification (DS), Functional Requirements Specifications (FRS), Functional Risk Assessment (FRA), Configuration Specification (CS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Traceability Matrix (TM), Validation Summary Report (VSR) and Software Release Certificate (SRC).
Reporting Team:
Reporting Designation: DGM – ITQA
Reporting Department: ITQA
Educational qualifications preferred:
Field specialization: Pharma/ Science
Degree: M. Pharma, M. Sc.
Academic score: 1st Class preferred
Required Certification/s: CSV
Required work experience:
Industry: Pharmaceuticals
Time Constraints: #*Time Constraints*#
Compliance Related: #*Compliance Related*#
Union Affiliation: #*Union Affiliation*#
