Executive - QA - IT-CSV

Role Objective

To ensure the implementation, validation, review, and maintenance of Computer System Life Cycle methodologies for computerized systems and automated manufacturing and laboratory systems in compliance with 21 CFR Part 11, GAMP 5, applicable IT standards, and internal quality requirements.

The role focuses on maintaining computerized systems in a validated state throughout their lifecycle, ensuring robust validation documentation, accurate testing, periodic review, re-qualification, and appropriate oversight of IT controls that support regulated GxP operations.

Desired Candidate Profile

• Bachelor's degree in Computer Science, Information Technology, Pharmacy, or a related field.
• Strong working knowledge of 21 CFR Part 11, GAMP 5, Computer System Validation (CSV), and IT compliance requirements.
• Hands-on experience preparing and reviewing validation documentation, including User Requirement Specifications (URS), SOPs, test protocols, and supporting validation records.
• Experience in software testing and validation of computerized systems used in manufacturing and laboratory environments.
• Working knowledge of change control, deviations, CAPA, project validation, system re-qualification, and periodic review requirements.
• Ability to coordinate validation activities with business users, Quality, IT, and other cross-functional stakeholders within defined timelines.

Roles & Responsibilities

• Implement Computer System Validation methodologies across the full system lifecycle.

Apply Computer System Life Cycle methodology in line with 21 CFR Part 11 and GAMP 5 across Concept, Planning, Testing, Operation, and Retirement phases.

Assess computerized systems, automated manufacturing process controls, and laboratory systems for applicable validation and compliance requirements.

• Own validation planning, testing, and requirements review for computerized systems.

Prepare and review User Requirement Specifications (URS) based on business-unit requirements.

Perform and document software testing against approved URS and defined acceptance criteria.

• Maintain compliant CSV documentation and quality-system records.

Develop, review, and maintain SOPs, test protocols, change controls, deviations, CAPA records, and other validation documentation.

Ensure documentation is accurate, complete, traceable, and compliant with applicable regulatory and internal quality standards.

• Conduct periodic review and ongoing monitoring of validated computerized systems.

Perform periodic reviews to confirm that systems remain in a validated and compliant state.

Review IT controls and activities including user management, backup and restoration verification, time synchronization, and IT security policy compliance.

• Plan and execute project validation and system re-qualification.

Deliver validation and re-qualification activities within agreed timelines and regulatory requirements.

Optimize resource utilization while maintaining the quality of validation documentation, testing, and review.

Functional Skills Required

• Strong understanding of Computer System Validation (CSV), Computer System Life Cycle methodology, 21 CFR Part 11, and GAMP 5.
• Proficiency in preparation and review of URS, SOPs, validation plans/protocols, test records, and associated lifecycle documentation.
• Hands-on capability in software testing and validation for manufacturing process-control and laboratory computerized systems.
• Knowledge of change control, deviations, CAPA management, project validation, periodic review, and system re-qualification.
• Understanding of IT controls relevant to GxP systems, including user access management, backup/restore verification, time synchronization, and IT security compliance.
• Ability to assess system compliance, identify gaps, document findings, and support timely remediation.

Behavioral Skills Required

• Attention to detail - maintains thorough, accurate, and traceable validation documentation and testing evidence.
• Problem-solving - identifies and resolves issues related to computerized-system validation and compliance effectively.
• Execution discipline - manages multiple validation and re-qualification activities to meet agreed timelines without compromising documentation quality.
• Communication - communicates clearly in writing and verbally and collaborates effectively with business users and cross-functional teams.
• Analytical thinking - assesses system risks and requirements and interprets regulatory expectations to support compliant implementation.
• Quality mindset - maintains a compliance-first approach throughout the computerized-system lifecycle.

Non-Negotiable Requirements (Immediate Disqualifiers)

Regardless of overall profile strength, the following would make a candidate unsuitable for this role:

• No practical understanding of Computer System Validation principles or the computerized-system lifecycle.
• No working knowledge of 21 CFR Part 11 and GAMP 5 requirements applicable to regulated computerized systems.
• No hands-on exposure to URS, validation protocols, software testing, or validation documentation.
• Unable to demonstrate understanding of periodic review, change control, deviations, CAPA, or re-qualification in a regulated environment.
• Insufficient documentation discipline for a quality-assurance role supporting GxP computerized systems.

Reporting Structure

The role operates within Quality Assurance - CSV (IT) and works cross-functionally with IT, manufacturing, laboratory, and business-user teams. The specific reporting designation is to be aligned with the approved organization structure.

Job Location

Pharmez Unit-II & Khatraj Unit-III

Important Links

Website: https://biotechhealthcare.com/

LinkedIn: https://www.linkedin.com/company/biotechhealthcare/

Instagram: Biotech Vision Care

Biotech is an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground including gender, race, religion, age, sexual orientation, disability, etc.