Ajanta Pharma Hiring for Computer System Validation (CSV) – Officer

Ajanta Pharma Limited, a renowned name in the pharmaceutical industry, is seeking talented individuals for the position of Computer System Validation (CSV) – Officer at its state-of-the-art US FDA-approved formulation facility in Paithan, Chhatrapati Sambhajinagar, Maharashtra. This role is perfect for candidates with a solid foundation in computer system validation, regulatory compliance, and risk-based methodologies.

About Ajanta Pharma Limited

Ajanta Pharma Limited is a globally recognized pharmaceutical company, celebrated for its innovation and commitment to excellence. With a strong presence in regulated markets like the US, Europe, and emerging markets, Ajanta Pharma is dedicated to delivering high-quality healthcare solutions that make a difference.

Role Details: Computer System Validation (CSV) – Officer

Job Location

• Facility: US FDA-approved formulation plant
• Address: B-4/5/6, MIDC Area, Paithan, Dist. Chhatrapati Sambhajinagar, Maharashtra, 431148

Experience Required

• Years of Experience: 4 to 7 years

Educational Qualifications

• Degrees: BSc., MSc., or BE in Computer Science

Key Responsibilities

As a CSV Officer at Ajanta Pharma, you will:

1. Execute and manage computer system validation activities, ensuring compliance with regulatory requirements.
2. Stay updated with international regulatory guidelines such as FDA, EMA, WHO, and ICH.
3. Apply risk-based validation methodologies in line with GAMP 5 and 21 CFR Part 11 standards.
4. Collaborate with cross-functional teams to validate IT infrastructure, databases, and ERP systems.
5. Maintain validation documentation and perform regular audits for compliance assurance.

Candidate Profile

The ideal candidate for this position should have:

• Regulatory Expertise: Familiarity with FDA, EMA, WHO, and ICH guidelines.
• Technical Knowledge: A strong grasp of IT infrastructure, databases, and ERP systems.
• Validation Proficiency: Hands-on experience with GAMP 5, 21 CFR Part 11, and risk-based methodologies.
• Communication Skills: Ability to collaborate effectively with teams across the organization.

How to Apply

Interested candidates are encouraged to apply by sharing their resumes at:
📧 Email: cv.ptn@ajantapharma.com

Address for Correspondence:
Ajanta Pharma Limited,
B-4/5/6, MIDC Area, Paithan,
Dist. Chhatrapati Sambhajinagar, Maharashtra, 431148

🕒 Application Deadline: January 25, 2025