Job Description

Computer System Validation Analyst is ultimately responsible for the overall quality and risk management activities of the software development project for our pharmaceutical client. This resource will utilize his/her analytical and technical skills to design and execute validation protocols for systems, manufacturing equipment or processes to produce products meeting internal and regulatory standards.Use computer systems validation expertise in the V Model SDLC for all systems that support GxP activities. Ensure compliance with  21 CFR Part 11, and EU regulations regarding validation of electronic records and electronic signatures.

RESPONSIBILITIES

• Organize the daily operations of the validation group to assure that master plans, protocols, and reports are generated and approved within predetermined timelines.
• Develop, implement, and maintain compliance management plan to FDA, GMP, 21 CFR Part 11 and other related Federal, State and Local regulations or standards, as it applies to the client’s business.
• Apply validation and regulatory affairs expertise to facilitate discussion to perform risk assessment and define system criticality according to GMP (Good Manufacturing Practices), GAMP (Good Automated Manufacturing Practice) and FDA regulations and pharmaceutical client SOPs.
• Author the typical compliance and regulatory affairs validation documentation such as QAP, Validation Plans/Summaries, Test Plans/Summaries, Trace Matrix, Qualification Protocols (IQ/OQ/PQ) and scripts, Testing Defects, QASR etc

QUALIFICATIONS

• Bachelor’s Degree in life sciences, engineering, or related.
• 1-5 years’ of experience in a regulated environment (Pharmaceutical/Biotech/Medical Device/Therapeutic)
• Demonstrated experience and excellent knowledge of applicable CSV and other applicable regulations GAMP guidance.
• Good knowledge of Project Management and Software Development Life Cycles.
•  Familiarity with computer infrastructure, servers, workstations, operating systems and data base management systems.

Company Description

White Collar Technologies is a boutique human capital consultancy firm specializing in information technology and engineering consulting for life science sector. Our consultants serve multitude of clients within Pharmaceutical, Biotech, Medical Device, Clinical Research and Healthcare verticals. We offer our workers Medical Dental and Vision healthcare benefits.