Description

You will develop, implement, and manage validation strategies to ensure compliance with GxP, CSV, and regulatory standards for pharmaceutical processes.

This role is on-site.

Responsibilities

• Create and maintain validation plans, schedules, and documentation including validation master plans.
• Lead process, packaging, and cleaning validation activities aligned with regulatory and business requirements.
• Establish procedures, templates, and documentation standards for validation processes.
• Monitor compliance, support audits, and ensure adherence to SOPs and global regulatory expectations.
• Collaborate with cross-functional teams to prioritize validation activities and ensure timely execution.

Required Skills

• 6–8 years of experience in pharmaceutical validation, compliance, or IT quality roles.
• Strong expertise in GxP, CSV, 21 CFR Part 11, and validation processes (IQ/OQ/PQ).
• Proficiency with HP ALM, JIRA, and X-Ray tools.
• Experience with Agile methodologies and global delivery models.
• Bachelor’s degree in Life Sciences, Engineering, Information Systems, or a related field.
• Proven experience with validation documentation in regulated environments.

Key Skills

Education

Any Graduate