What are the responsibilities and job description for the Validation Lead position at Katalyst Healthcares & Life Sciences?
Roles and Responsibilities:-
- Work with facility Subject Matter Experts to document user requirements.
- Update application system User Requirements, Functional, and Design Specifications.
- Develop Installation Qualifications based on Design.
- Develop Operation Qualifications based on functional requirements.
- Develop Performance Qualification scripts based on configuration.
- Route validation documentation. Perform test execution or lead execution activity.
- Validation experience with enterprise computer systems (ERP, LIMS, QMS, ECM, LMS, etc.) within the pharmaceutical industry.
- Minimum 3 to 5 years in pharmaceutical industry, focusing on Validation.
- Thorough understanding of the principles of computer systems validation, SDLC methodologies and testing best practice.
- Knowledge of cGMP, GDP, GAMP, 21CFR Part11 and industry best practices.
- Ability to understand existing and new business processes and requirements toensure proper implementation and validation of systems.
- Strong technical background.
- Strong communication and interpersonal skills ensuring the ability to interact with the business, peers and vendors in a professional manner.
- Ability to work independently with minimal supervision and adhere totimelines.
- University certificate or degree with a minimum of 5 years of related industry exp, or BS in Technology & 2-3 years of exp.
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