What are the responsibilities and job description for the Computer Systems Validation position at TekOne IT Services Pvt. Ltd.?
We are seeking an experienced Computer Systems Validation (CSV) Engineer for a 6-month contract role in Boston, MA. The ideal candidate will play a key role in executing computer systems validation activities and ensuring compliance with regulatory requirements for quality control (QC) lab environments.
Responsibilities
Execute Computer Systems Validation (CSV) activities, including requirements gathering, IQ/OQ/PQ protocol generation, test case execution, and report generation.
Collaborate with QA teams and work closely with vendors to ensure proper validation processes are in place.
Ensure compliance with GxP regulations, including GLP/GMP, 21 CFR Part 11, and lab systems validation.
Manage and resolve incidents, deviations, and CAPA (Corrective and Preventive Action) processes.
Perform onsite validation activities, coordinating with cross-functional teams to support validation efforts.
Maintain and update validation documentation according to company SOPs and industry standards.
Qualifications:
7 years of experience in Computer Systems Validation for QC labs.
Strong knowledge of GxP regulations, including GLP/GMP, 21 CFR Part 11, and validation of lab systems.
Proficient in managing incidents, deviations, and CAPA processes.
Ability to work collaboratively with cross-functional teams and on-site.
Bachelor’s degree in Computer Science or a related field.
Key Skills:
CSV experience in QC Labs.
Strong familiarity with GxP regulations and 21 CFR Part 11.
Knowledge of GLP/GMP environments and validation processes.
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