Validation Lead – Pharma/Life Science – 58055

We have an immediate opportunity with one of our key clients for a position of Validation Lead – Pharma/Life Science, to work in Raritan, NJ.

Pay Rate: $60 – $65/hr on C2C

Responsibilities:

• Validate systems used in R&D/Clinical and PLM pillars.
• Validate data migration projects, ensuring compliance with FDA and global regulatory standards.
• Write and execute documentation for all aspects of validation deliverables, including requirements, validation plans, test protocols, test summary reports, and validation reports.
• Review system tests, user acceptance test scripts, traceability matrix, and design specifications.
• Ensure documentation complies with company standards and industry regulations.
• Implement and oversee QA methodologies, including designing, reviewing, and approving test plans, systems, UAT test scripts, and test procedures.
• Provide validation guidance, timely reviews, and escalations to Technology Quality Management.
• Lead and mentor a team of validation specialists.
• Provide training to ensure an adequate supply of trained manpower in the required technology.
• Work collaboratively with remote teams and support multiple projects simultaneously.
• Ensure that all validation activities meet GxP standards and are aligned with FDA guidance and industry standards such as GAMP.
• Maintain up-to-date knowledge of FDA and global regulatory environments.
• Gather specifications and deliver solutions to the client organization based on domain or technology understanding.
• Recommend client value creation initiatives and implement industry best practices.
• Identify and mitigate risks associated with validation projects.

Skills:

• Expertise in validating systems within the pharmaceutical industry.
• Deep understanding of GxP standards and risk-based validation.
• Knowledge of FDA guidance and industry standards (e.g., GAMP).
• Strong experience in writing and executing validation documentation.
• Proficient in QA methodologies, including designing and reviewing test plans.
• Excellent verbal and written communication skills.
• Ability to lead teams, work independently, and manage multiple projects simultaneously.

For immediate consideration, please contact:

Tushar

PRIMUS Global Services

Direct: 972-486-9123

Phone No: 972-753-6500 Ext: 406

Email: [email protected] 

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