GxP Validation and Compliance Specialist

5 days ago

Bengaluru, Karnataka, India micro1 Full time ₹ 20,00,000 - ₹ 25,00,000 per year

Job Title
: GxP Validation and Compliance Specialist

Job type:
Full-time, Contract

Location:
Hybrid (Bengaluru, Hyderabad, Delhi, Pune)

About Us:

Our mission at micro1 is to match the most talented people in the world with their dream jobs. If you are looking to be at the forefront of AI innovation and work with some of the fastest-growing companies in Silicon Valley, we invite you to apply for a role. By joining the micro1 community, your resume will become visible to top industry leaders, unlocking access to the best career opportunities on the market.

Job Summary:

Join our customer's team as a GxP Validation and Compliance Specialist and drive excellence in risk-based validation and regulatory compliance within a dynamic, on-site environment. Leverage your expertise in computer system validation (CSV/CSA) and GxP regulations to ensure robust, audit-ready documentation and controls for electronic records and signatures. This is an impactful role that will shape quality standards and regulatory adherence across multiple business-critical operations.

Key Responsibilities:


• Lead and execute risk-based validation strategies for computer and automated systems compliant with GxP requirements.


• Develop, review, and maintain validation protocols, reports, and life cycle documentation in accordance with CSV/CSA best practices.


• Ensure compliance with relevant regulatory frameworks (FDA, EMA, MHRA, etc.) governing electronic records and electronic signatures (ER/ES).


• Design, implement, and review audit trails for critical systems to ensure data integrity and traceability.


• Support and prepare for regulatory inspections and internal/external audits by maintaining thorough documentation and readiness.


• Provide expert guidance on deviation management, CAPA, and change control processes for GxP-related systems.


• Collaborate cross-functionally to drive continuous improvement and knowledge sharing on validation and compliance topics.

Required Skills and Qualifications:


• Demonstrated proficiency in risk-based computer system validation (CSV) and/or computer software assurance (CSA).


• In-depth knowledge of regulatory requirements for GxP, including 21 CFR Part 11, Annex 11, and associated guidance.


• Hands-on experience with audit trail design and management in a regulated environment.


• Proven expertise in electronic records and electronic signatures (ER/ES) compliance.


• Exceptional written and verbal communication skills, with a strong focus on accuracy and clarity.


• Excellent organizational skills with the ability to manage multiple projects and deadlines.


• Strong problem-solving mindset, attention to detail, and a proactive approach to compliance challenges.

Preferred Qualifications:


• Professional certification in GxP compliance, validation, or regulatory affairs.


• Prior experience supporting global regulatory audits and inspections.


• Experience in life sciences, pharmaceuticals, or biotechnology sectors.

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