Group Company: Glenmark Pharmaceuticals Limited

Designation: Executive

Office Location: Chhatrapati Sambhajinagar

Position description: ITQA

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*#