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Quality Assurance Validation Specialist
2 months ago
IDR, Inc. is currently seeking a Validation Engineer to support our esteemed clients. This role is a fully onsite contract opportunity that offers a chance to engage with a large organization and contribute to a collaborative team environment.
Key Responsibilities for the Validation Engineer:
- Maintain quality assurance and compliance in line with established protocols and regulations.
- Create, evaluate, and authorize foundational documents including Validation Plans, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Design Specifications (DS), and Standard Operating Procedures (SOPs).
- Develop, review, and execute computer validation documentation (Installation Qualification, Operational Qualification, and Performance Qualification) for GxP systems originating from Quality Control Units.
- Establish, implement, and uphold controlled documents related to computer system validation to facilitate the initiation, validation, operation, and maintenance of GxP systems.
- Assist in managing change controls, Corrective and Preventive Actions (CAPAs), deviations, and exceptions necessary for system validation processes.
- Support administrative and maintenance functions for laboratory systems.
Essential Qualifications for the Validation Engineer:
- A minimum of 6 years of experience in the pharmaceutical sector with a focus on Good Manufacturing Practices (GMP).
- Proficient in the validation of current Good Manufacturing Practice (cGMP) automation within FDA-regulated settings.
- Familiarity with the phases of the Life Cycle Validation approach.
- Knowledgeable in GAMP 5, 21 CFR Part 11 and Part 211, EudraLex Volume 4 and Annex 11, as well as ICH Q7, Q8, Q9, and Q10.
- Capability to manage multiple projects simultaneously.
- Bachelor's Degree in Engineering, Science, or a related technical discipline.
Benefits of this Position:
- Competitive salary and compensation package.
- Comprehensive benefits including Medical, Vision, Dental, and more.
- Opportunity to work with a leading organization in the industry.
- A supportive and team-oriented work culture.
Why Choose IDR?
- Over 25 years of proven experience across four major markets.
- Employee Stock Ownership Program.
- A dedicated Engagement Manager focused on your success.
- Medical, Dental, Vision, and Life Insurance coverage.
- Recognized as ClearlyRated's Best of Staffing Client and Talent Award winner for ten consecutive years.
