Sr. Validation Software Specialist

2 weeks ago

Pensacola, United States Nelson Laboratories Holdings, LLC Full time

Nelson Laboratories Holdings, LLC

Sr. Validation Software Specialist

SALT LAKE CITY ,

Utah

Apply Now

The Sr. Software Validation Specialist role is an exempt level position with responsibilities for providing quality oversight over the validation and qualification activities for computer systems and processes to support both clinical and commercial requirements in a GXP environment. This role with develop CSV gap assessments and remediation plan with an understanding of applying risk management principles. This role will also provide oversight of qualification and validation activities including data or document review and approval as needed. This role will be responsible for reviewing and approving qualification protocols, reports, and any associated documentation in support of computer systems validation, facility qualification, and data integrity for computerized systems as well as non-computerized systems. This role will support audits as the CSV subject matter expert and develop CSV gap assessments. Essential Duties:Provide quality oversight over the validation and qualification activities for computer systemsand processes to support both clinical and commercial requirements in a GMP environmentProvide quality oversight on GXP computerized systems implementation and coordinate withthe Software Validation team to complete validation activitiesProvide oversight and review of qualification and validation activities including review andapproval of qualification protocols, reports, retirement, and any associated documentation insupport of computer systems validation and data integrity of computerized systemsReviews master and completed computer system(s) qualification and validation protocols,summary reports and associated data for conformance to regulations, SOPs, specification,and other applicable acceptance criteriaReview and approve change controls, SOPs, deviations, and CAPAs associated withqualification/validation execution and ensure effectiveness of related actionsProvide expertise and solutions to issues regarding Software Quality Management andSoftware Development Life Cycle (SDLC) strategies and documentationProvides guidance on industry best practices, and quality requirements for maintaining acompliant state for all site systemsFacilitates and collaborates in the development of computer system related policies, SOPs,procedures, templates, and formsDevelops and evaluates quality processes and system standards to ensure compliance withapplicable policies, industry standards, and global regulationsAssess equipment/systems for 21 CFR Part 11, GAMP 5 and Annex 11 requirementsWorks with IT and global compliance partners to ensure configuration and documentation ofcomputerized systems to meet the requirements of CFR21 Part 11Interacts with Business System Analysts, Software Validation Specialists, other Quality andTechnical positions proactively to assess, and guide in the deployment of ComputerizedsystemsPerform tasks in a manner consistent with the safety policies, quality systems, and cGMPrequirementsDevelops CSV Gap Assessments and Remediation Plans with an understanding of applyingrisk management principlesCommunicate all identified compliance and quality risks to his/her supervisor and allappropriate partiesSupports regulatory and client audits as CSV subject matter expertDrive continuous improvementOther duties as necessary Regulatory ComplianceFollow applicable regulatory requirements (GMP, GLP, ISO, etc.)Follow company policies and procedures Competencies of this positionStrong interpersonal and written/oral communication skillsAbility to quickly process complex information and make critical decisions with limitedinformationAbility to work independently and be responsible for a portfolio of ongoing projectsAbility to pay attention to details and follow procedures closelyMust be highly organized and capable of working in a team environment with a positiveattitude under minimal supervisionDetail oriented and flex ble in a dynamic working environmentStrong proficiency with using Microsoft Office applications Work Environment:This job operates in a professional office and laboratory environment. This role routinely uses standardoffice equipment such as computers and phones.Travel requirements.Occasional travel during the business day. Some out-of-the area and overnight travel may beexpected. Physical requirements:Must be able to stand/walk for 10% of the day and 90% of the day sitting at a desk or on thecomputer.Must be able to occasionally lift a maximum of 45lbs. Education and experience requirements:Bachelor's Degree in Computer Science or equivalent technical discipline5+ years relevant work experiencePrefer experience working in a regulated facility, ideally in quality assurance, manufacturingcompliance, or clinical qualityQuality assurance experience in Pharma or Medical Device industry preferredKnowledge of GxP regulations and FDA/EU guidance related to GMP manufacturing ofpharmaceuticals and/or preclinical biocompatibility assessments (FDA or OECD GLP) preferredStrong knowledge of GxP compliance as it applies to Computer Systems, 21 CFR Part 11, EUANNEX 11, GAMP 5 Validation Lifecycle, Business Analysis and Computer Systems (rangingfrom validated Excel spreadsheets, critical applications, software, IT infrastructure (hardware)AUX1060 Rev 4Knowledge of expectations on IT Cloud compliance requirements and emerging industryregulations and guidance (GAMP, OECD 17, OECD 22) or interest in becoming familiarExperience in cGMP regulatory body auditsExperience reviewing/auditing GMP documentationAbility to identify and assess possible gaps and work collaboratively to address such issues Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity

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