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Senior Computer System Validation Analyst, ERP system

Company: Lantheus
Location: Billerica
Posted on: July 29, 2022

Job Description:

This is a key technical role responsible for Quality oversight on Computer System Validation GMP systems. Including but not limited to author, review and approve validation documentation, and strategic planning, maintaining compliance of computerized operations in a GMP environment. The position will primarily focus on the implementation of a new Enterprise Resource Planning (ERP) system. In additional, the position will provide QA support to GMP information systems and software applications in areas of QMS, laboratory, manufacturing and clinical information management systems and computerized instrumentation.Key Responsibilities/Essential FunctionsQA CSV Lead for the ERP implementation, focus on SAP will be a plus.Oversee the development, and approval, of computer system validation documents, including validation plans and protocols, test scripts for the SAP implementationAccountable for initiation/preparation and closeout of all CSV related change control documents and quality events.Implement appropriate validation methodologies as per company procedures in collaboration with Business and system owners.Work with overall project manager to include validation activities in implementation timelinesReview and analyze the user and functional requirements using risk-based approach.Evaluate proposed changes to validated computer systems and recommend level of validation activities requiredSupport the identification and qualification of all computer systems which impact cGMP operations using a risk-based methodologyAuthor and/or review validation documentation - such as user requirements, functional requirements, configuration specification, Validation Master Plan (VMP), IQ/OQ/PQ documentation, GxP criticality assessments, Electronic Records Electronic Signature (ERES) assessments, Data Integrity (DI) assessments, test scripts, trace matrix requirements, deviations, validation summary reports, and system use documentation (system admin, user admin procedures).Oversee the decommissioning of GMP software systems.Work closely with IT and business owners to ensure appropriate validation of cGMP computer systemsCoordinate audits of internal computer systems validation activities, protocol and proceduresSupport and executionof a risk-based clinical quality audit plan for assigned programsDuties may include internal compliance or efficiency improvement efforts within CSV department.Ensure that SOP's and procedural methodologies employed to maintain the validated state are reviewed and updated as needed.Provides active role in the continuous improvements of CSV processes and methodologies as per current regulations.Basic Qualifications3 - 5 years of CSV experience in FDA regulated industry- focus on ERP / SAP2+ years pharmaceutical/Life Sciences manufacturing industry experience2+ years in computer systems validation, process validation, QA or compliance functionsBS degree in Computer Science or Life ScienceExcellent understanding and experience with current industry regulations, standards, guidelines, and practices.Good knowledge of quality systems and quality eventsGood knowledge and understanding of 21 CFR Part 11 as well as regulations around GCP, GLP and GMP.Good communication/interpersonal skillsGood writing skills for validation documentations and SOPsOther RequirementsHybrid remote position for MA residents / able to work on US East coast time zone.

Keywords: Lantheus, Billerica , Senior Computer System Validation Analyst, ERP system, Professions , Billerica, Massachusetts

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