LABUR
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Computer System Validation Specialist
role at
LABUR
Our client is seeking a
Computer System Validation Specialist
who will play a crucial role in ensuring that IT systems comply with regulatory guidelines. This role involves the validation process, including creating and executing test plans, documentation, and change control, to maintain data integrity and compliance standards. Key Responsibilities
Develop and execute validation protocols for computer systems. Ensure compliance with regulatory requirements such as FDA 21 CFR Part 11, GxP, and ISO standards. Create detailed validation documentation including plans, reports, and scripts. Conduct risk assessments and impact analyses related to computer systems. Coordinate and supervise testing activities. Collaborate with cross-functional teams to maintain and improve system validation processes. Monitor and report on validation project progress. Provide training and support to staff regarding validation processes and requirements. Qualifications
3+ years of experience in computer system validation. Familiarity with regulatory requirements such as FDA 21 CFR Part 11, GxP, and ISO standards. Strong understanding of software development and validation lifecycle. Excellent documentation and technical writing skills. Strong analytical and problem-solving capabilities. Ability to work independently and in a team environment. Additional Details
Seniority level: Mid-Senior level Employment type: Contract Job function: Information Technology Industries: IT Services and IT Consulting Referrals increase your chances of interviewing at LABUR by 2x. Get notified about new Computer Specialist jobs in
Bedford, MA . Interested in other roles? Join our Talent Pool! #J-18808-Ljbffr
Computer System Validation Specialist
role at
LABUR
Our client is seeking a
Computer System Validation Specialist
who will play a crucial role in ensuring that IT systems comply with regulatory guidelines. This role involves the validation process, including creating and executing test plans, documentation, and change control, to maintain data integrity and compliance standards. Key Responsibilities
Develop and execute validation protocols for computer systems. Ensure compliance with regulatory requirements such as FDA 21 CFR Part 11, GxP, and ISO standards. Create detailed validation documentation including plans, reports, and scripts. Conduct risk assessments and impact analyses related to computer systems. Coordinate and supervise testing activities. Collaborate with cross-functional teams to maintain and improve system validation processes. Monitor and report on validation project progress. Provide training and support to staff regarding validation processes and requirements. Qualifications
3+ years of experience in computer system validation. Familiarity with regulatory requirements such as FDA 21 CFR Part 11, GxP, and ISO standards. Strong understanding of software development and validation lifecycle. Excellent documentation and technical writing skills. Strong analytical and problem-solving capabilities. Ability to work independently and in a team environment. Additional Details
Seniority level: Mid-Senior level Employment type: Contract Job function: Information Technology Industries: IT Services and IT Consulting Referrals increase your chances of interviewing at LABUR by 2x. Get notified about new Computer Specialist jobs in
Bedford, MA . Interested in other roles? Join our Talent Pool! #J-18808-Ljbffr