Job Description

Department Details
Role Summary
Job Purpose:
To ensure the effective functioning, maintenance, and compliance of process and RND laboratory instrumentation and equipment. The role involves CSV, CQV, Change control, CAPA & Deviation management, QMS, Validation, calibration, documentation, audit support, and cross-functional coordination, in adherence to quality and regulatory standards.
Key Responsibilities:

• Prepare, review, and execute CSV deliverables for new and existing enterprise & scientific applications (e.g., Unicorn, Chromeleon, Biacore Control, LIMS), laboratory instruments / equipment and R&D systems.
• Develop and implement validation strategies in alignment with GAMP 5, 21 CFR Part 11, and EU Annex 11 guidelines.
• Perform risk assessments to identify and mitigate software-related risks impacting data integrity, product quality, patient safety, and compliance.
• Manage end-to-end validation for all software categories (Category 1, 3, 4, & 5) in a regulated GxP environment.
• Prepare IT Infrastructure Qualification documentation including for servers, networks, cloud environments, and on-prem systems.
• Execute periodic reviews of GxP computerized systems to ensure continued compliance and system suitability.
• Manage QMS records such as Change Control, CAPA, and Deviation related to software and Instruments/Equipment.
• Perform vendor assessments, GxP assessments, and maintain traceability across the validation lifecycle.
• Support system audit trail reviews, user management, backup/restore validation, and password/access control procedures.
• Prepare and maintain equipment qualification documentation (IQ/OQ/PQ) including calibration and Requalification.

Technical / Functional Skills:

• Strong knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles.
• Hands-on experience in validating LIMS, TrackWise, SCADA, CDS (e.g., LabSolutions, Chromeleon), and PLC/SCADA-based systems.
• Proficient in authoring CSV documentation: URS, FRA, IQ/OQ/PQ, Traceability Matrix, Validation Summary Reports.
• Working knowledge of quality systems, QMS tools, and validation project management.
• Familiarity with cGMP, GDP, and regulatory compliance
• Understanding of audit readiness and documentation standards
• Strong time management, communication, and coordination skills

Qualifications:

• Bachelor's or Master's degree in Life Sciences, Computer Science, Engineering, or a related discipline.
• Certification in CSV, GAMP, or related regulatory compliance (preferred).

Key Responsibilities
Experience:

• 1-5 years of relevant experience in Computer System Validation within a regulated pharmaceutical/biotech/medical devices industry.
• Experience validating both off-the-shelf and custom-developed applications in a GxP setting.

Key Competencies:

• Attention to detail and strong documentation skills.
• Analytical thinking and risk-based decision-making.
• Effective communication and stakeholder collaboration.
• Regulatory awareness and audit readiness.
• Time management and ability to prioritize tasks under tight timelines.
• Strong understanding of software/system lifecycle and validation best practices.

Educational Qualifications
Required Education Qualification: B.CA
Required Experience: 1 - 3 years