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.