Randstad Computer Systems Validation Specialist in North Billerica, Massachusetts
Computer Systems Validation Specialist
location:North Billerica, MA
date posted:Monday, June 19, 2017
Oversight of Computer Systems Validation (CSV) projects related to authoring and executing specifications and validation documentation according to the GAMP5 Validation Life Cycle, including: Computer System Validation Plan, System Requirement Specification (SRS), Risk Assessment, Functional Requirement Specification (FRS), Design Specification (Software and Hardware), Commissioning, IQ, OQ, PQ, Summary reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer Systems and Audit Trail review.
Ensure validation protocols are in line with corporate guidelines procedures, cGMP and ISPE GAMP guidelines and regulations.
Oversight of specific tests and requirements to be met in the IQ/OQ/PQ that address requirements.
Ensure all work is in line with the site Computer Master Validation Plan (VMP), regulations, procedures and practices.
Ensure that the site Computer VMP remains current and aligned with corporate policies.
Review and execute Computer System Validation protocols to ensure compliance and adherence with corporate guidelines procedures, CGMP and ISPE GAMP5 guidelines and regulations.
Review and Approve risks assessments and applicable test scripts according to GMP and 21 CFR Part 11 compliance guidelines and the Site Computer VMP.
Review and Approve computer validation summary reports for executed protocols.
Liaise with other departments in execution of the Validation program.
Communicate Computer System Validation approaches and requirements during audits.
Work with computer system owner(s) to ensure the initiation and implementation of change control activities are in accordance with site procedures.
Working hours: 8-5
BS/BA degree in a computer science/ business/technical discipline with a minimum of 8 years of experience in CSV in a pharmaceutical industry or related GMP environment, or equivalent.
In depth knowledge of FDA guidelines and Global cGMPs relevant to 21 CFR Part 11 compliance requirements and Global Computer System Validation and ISPE GAMP5 guidelines.
Excellent interpersonal skills with the ability to influence individual and teams across the organization in the absence of a direct reporting relationship.
Strong verbal and written communication skills, good decision making skills and time management skills is a must; ability to interface with all levels of the organization
May require Handling of and, or exposure to potentially hazardous chemical, radiological and or biological materials. Required to follow all safety procedures, and use personal and protective equipment provided.
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