Sr. Executive / Asst. Manager - QA (Computer System Validation (CSV) )

Why This Role Matters

In today’s pharmaceutical and research-driven environment, computerized systems are at the core of quality, compliance, data management, and regulatory reporting. Ensuring that these systems function accurately, securely, and in compliance with global regulatory expectations is critical for patient safety, product quality, and organizational credibility.

The QA – Computer System Validation (CSV) role at B&S Group, Gowrie Research Pvt. Ltd., Vadodara plays a vital role in safeguarding data integrity and ensuring that all GxP computerized systems meet stringent regulatory standards such as 21 CFR Part 11 and other global compliance frameworks. This position directly impacts regulatory readiness, audit success, and operational excellence.

By joining this role, professionals contribute to building a robust compliance culture while supporting innovation in R&D, analytical development, and project-driven pharmaceutical operations.

Job Description

B&S Group, Gowrie Research Pvt. Ltd., Vadodara is conducting a Walk-In Drive for Women Professionals from 23rd to 27th February 2026, offering an opportunity in QA – Computer System Validation (CSV). The organization is seeking an experienced and technically strong M.Pharm professional with 7–10 years of relevant experience in computerized system validation within pharmaceutical or regulated environments.

The selected candidate will be responsible for ensuring lifecycle validation, regulatory compliance, risk assessment, and documentation control for computerized systems used in Quality Assurance, R&D, Analytical Development Laboratory (ADL), and other regulated functions.

This role requires a strong understanding of GxP requirements, regulatory guidelines, data integrity principles, and system validation methodologies. The position demands close coordination with cross-functional teams including IT, QA, regulatory, and user departments to ensure system compliance from implementation through ongoing operation.

Key Features of the Role

Opportunity to lead validation of critical computerized systems in a regulated pharmaceutical environment.
Direct exposure to regulatory compliance standards including GxP and 21 CFR Part 11.
Involvement in R&D and special product development support systems.
Participation in regulatory inspections, internal audits, and compliance improvement initiatives.
Women-focused empowerment hiring initiative promoting leadership and technical excellence.
Structured career progression within QA and regulatory compliance domains.

Responsibilities Required

Lead and manage validation activities for computerized systems across departments including Quality, R&D, Analytical Development, and Project Management.

Prepare, review, and approve validation documentation such as User Requirement Specifications (URS), Functional Specifications (FS), Design Specifications (DS), Risk Assessments, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Validation Summary Reports.

Ensure compliance of all computerized systems with applicable regulatory requirements including GxP guidelines and 21 CFR Part 11 standards for electronic records and electronic signatures.

Conduct risk-based assessments to identify potential compliance gaps and recommend corrective and preventive actions.

Review vendor documentation, system configuration details, and qualification packages to ensure regulatory adequacy before system deployment.

Monitor and evaluate change control activities related to system upgrades, patches, software enhancements, and configuration changes. Ensure appropriate impact assessment and revalidation activities are conducted.

Support regulatory inspections and internal audits by providing complete validation documentation and addressing compliance-related queries.

Ensure implementation of robust data integrity controls including audit trail reviews, user access management, password policies, backup and recovery systems, and periodic system reviews.

Collaborate with IT and software vendors to ensure secure system architecture, validation compliance, and continuous performance monitoring.

Maintain proper documentation practices, version control, and archival procedures in alignment with Quality Management System (QMS) requirements.

Provide training and awareness sessions to cross-functional teams regarding CSV lifecycle approach, data integrity expectations, and regulatory updates.

Participate in continuous improvement initiatives to enhance validation efficiency, documentation standards, and compliance readiness.

Qualifications

Candidates should possess a strong technical and regulatory background with demonstrated experience in Computer System Validation within pharmaceutical or regulated environments.

Educational Requirements:

Master of Pharmacy (M.Pharm) from a recognized university or institution.

Experience and Skills:

7–10 years of relevant experience in QA – Computer System Validation within pharmaceutical, biotech, or regulated research environments.

In-depth knowledge of GxP requirements and 21 CFR Part 11 compliance.

Strong understanding of lifecycle-based validation approaches and risk-based methodologies.

Hands-on experience in preparation and execution of IQ, OQ, PQ protocols.

Experience handling regulatory audits and inspection readiness activities.

Strong documentation, analytical, and review skills.

Excellent coordination and communication skills to manage cross-functional teams.

High attention to detail and ability to manage multiple validation projects simultaneously.

Salary Insights

Compensation will be competitive and aligned with industry standards for professionals with 7–10 years of CSV experience. Salary packages typically depend on candidate expertise, regulatory exposure, audit-handling capability, and leadership responsibilities.

Additional benefits may include:

Performance-based incentives
Professional growth opportunities in R&D and regulatory domains
Exposure to special product development projects
Women-focused empowerment initiative support
Structured performance evaluation and career progression pathways

Company Overview

B&S Group, Gowrie Research Pvt. Ltd., Vadodara is a reputed pharmaceutical research and development organization engaged in formulation development, analytical research, regulatory documentation, and quality compliance operations.

The organization emphasizes regulatory excellence, innovation-driven research, and structured Quality Management Systems. With strong focus on R&D, compliance, and specialized product development, the company provides professionals with an environment that supports technical growth, regulatory exposure, and leadership development.

Through its Women Professionals Walk-In Drive initiative, the organization aims to promote diversity, technical excellence, and inclusive leadership within the pharmaceutical and research ecosystem.

FAQs

1. Who is eligible to apply for this position?
   Women professionals with M.Pharm qualification and 7–10 years of relevant CSV experience in regulated pharmaceutical environments are eligible.

2. Is prior audit-handling experience required?
   Yes, experience in supporting regulatory inspections and internal audits is highly preferred.

3. What type of systems will be validated?
   Computerized systems used in Quality Assurance, R&D, Analytical Development, and related regulated functions.

4. Is knowledge of 21 CFR Part 11 mandatory?
   Yes, strong understanding of 21 CFR Part 11 and data integrity principles is essential for this role.

5. What is the selection process?
   Candidates can attend the walk-in interview between 23rd to 27th February 2026 with updated resume and educational documents.

Application Tips

Ensure your resume clearly highlights CSV projects handled, validation documentation prepared, and audit exposure.

Mention specific experience related to 21 CFR Part 11 compliance and GxP systems.

Include examples of risk assessments conducted and change control management handled.

Carry all relevant educational certificates, experience letters, and identification documents during the walk-in.

Prepare to discuss real-time validation scenarios, data integrity controls, and regulatory inspection experiences confidently.