Description

Job Responsibilities include:

Develop, implement, and manage validation strategies to ensure compliance with GxP, CSV, and regulatory standards.

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.

Collaborate with cross‑functional teams to prioritize validation activities and ensure timely execution.

Establish procedures, templates, and documentation standards for validation processes.

Monitor compliance, support audits, and ensure adherence to SOPs and global regulatory expectations.

Required Qualifications:

Bachelor’s degree in Life Sciences, Engineering, Information Systems, or a related field.

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) within regulated environments.

Proven experience with validation documentation, global delivery models, and tools such as HP ALM, JIRA/X-Ray, and Agile methodologies

Key Skills

Education

Any Graduate