Recruiters Comments: Our client is currently recruiting for an experienced CSV Engineer (Validation) for a permanent position within the pharmaceuticals & biotech industry in the mid-west region.
Our client is currently recruiting for an experienced CSV Engineer (Validation) for a permanent position within the pharmaceuticals & biotech industry in the mid-west region.
The Quality & Validation Specialist role is critical to the successful validation & compliance of our software. The primary responsibilities will be to ensure quality and compliance of our clients software product with respect to Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country specific), and current industry standards & best practices. Our software product is utilized by Pharmaceutical companies for the purpose of satisfying DQSA and other global compliance requirements.
DUTIES & RESPONSIBILITIES:
• Maintains working knowledge of FDA, EU & other global regulations and guidance governing GxP, Computer System Validation (CSV) and GAMP5 activities
• Ensures the quality & compliance of software development & operations activities with respect to internal procedures as well as FDA, ICH, EU and other country specific regulations
• Generates appropriate validation documents to support customer deployments and validation processes (e.g. User Requirement Specifications, Functional Specifications, Configuration Specifications, Design Specifications, Installation Qualification, Operational Qualification, Summary Reports, etc.)
• Executes and/or peer reviews appropriate validation documents (e.g. IQs and OQs) and prepares summary reports to customers per processes
• Assists with hosting customer audits
• Conducts periodic QA review of quality systems, operating procedures & policies
• Assists in the maintenance of GxP training files & in the compliance monitoring of staff GxP training
• Executes other duties as delegated
REQUIRED SKILLS & EXPERIENCE:
• Bachelor in a healthcare, engineering or scientific-related discipline is highly desirable
• 3-7 years of GxP/CSV quality assurance exp in a pharma or biotechnology industry
• Strong understanding of CSV related processes
• Good understanding of FDA & global pharma regulatory requirements & implementation, ideally with exp in the area of DQSA
• Strong knowledge of Computer System Validation in association with GxP audits
• Effective communication (verbal & written)
• Strong interpersonal skills, team player, and flexible without compromising quality
• Ability to manage multiple projects in a dynamic environment
• Occasional travel may be required based on the needs of our customer
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: Excellent benefits package on offer