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CSV(Lab System)

2 months ago

South Plainfield, United States Katalyst Healthcares and Life Sciences Full time

The incumbent will be a part of the IT Computerized System Validation (CSV) Department and will perform and/or direct GxP computerized system validation projects in compliance with cGMP, 21 CFR Part 11 and Annex 11. This individual will ensure that GxP systems meet intended uses and comply with applicable regulations, current industry practices, and Revance's policies and procedures. Validation projects may primarily include Lab systems and Steady-state activities around these systems.
Essential Duties/Responsibilities •Provide independent technical leadership and accountability for overall computer system validation efforts.
•Ensure quality and compliance in accordance with established procedures and standards of the Quality Systems by applying critical thinking to CSV work
•Generate, review, and approve base level documents such as Validation Plan, URS, FRS, DS, and SOPs in support of Computerized System Validation/Assurance activities
•Generate, review/approve and execute computer validation (IQ, OQ, and PQ) documentation for GxP systems from Quality Control Units
•Develop, implement, and maintain computer system validation-related controlled documents to support the initiation, validation, operation, and maintenance of GxP systems.
•Assist with change controls, CAPAs, deviations, and exceptions required as part of system validation efforts
•Support system administrative & maintenance activities for Lab Systems
•Support continuous improvement efforts by monitoring, tracking and performing the steady state activities for Lab Systems
•Perform gap analysis & necessary remediation efforts on current computer systems to ensure compliance with Part 11 and Annex 11.
•Collaborate/lead/participate in decision-making and make recommendations regarding the best options for validation of computer systems. Maintain close communication with stakeholders and team members to keep apprised of computer system needs, impact on computer system validation, project validation status, and other relevant issues
•Collaborate with Revance-approved vendor personnel in coordinating validation efforts including reviews/approvals of related validation deliverables and for ensuring a successful validation lifecycle.
•Reviews department-specific SOPs periodically and updates if/as needed to ensure that the procedures are always up to date based on the latest regulatory updates and industry best practices.
•Perform system assessments based on version upgrades/release updates on SaaS/Cloud-based GxP systems and ensure all the required verification and validation efforts are performed per the assessments conducted.
•Facilitate the computer system validation risk assessments i.e. System level, Requirement level risk assessments, & System and Data Audit Trail assessments, etc.
•Develop or assist with business process deliverables such as process flows, data flows, user/operating procedures, work instructions and forms for GxP computerized systems.
•Perform Periodic System Reviews ensuring that the systems maintain their validated status
•Support Regulatory inspections and internal and partner audits, and implements corrective actions as needed in CSV Education Minimum Required: Bachelor's degree in Engineering, Science, or a related technological field Preferred: Bachelor's degree in Pharmaceutical Science, Biomedical Engineering, or Management of Information Systems (MIS). Experience Minimum Required:
•Minimum of Six (6-8) years or more in the pharmaceutical industry with GMP experience.
•Understanding phases of Life Cycle Validation approach and practical working knowledge of computer system validation/computer software assurance requirements.
•Knowledge of validation of cGMP automation/computerized systems within an FDA regulated environments with a strong understanding of industry standards and best practices for computer validation such as GAMP 5, 21 CFR Part 11 and Part 211, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9 and Q10.
•Demonstrate ability to effectively manage multiple projects/priorities
•Demonstrate excellent written and oral communication skills.
•Effective time management and interpersonal skills.
•Must work effectively within teams with rapidly changing priorities.
•Demonstrates analytical problem-solving skills. Preferred:
•Relevant validation experience with Laboratory systems used within the pharmaceutical industry is a plus. Knowledge, Skills and Abilities Minimum Required: Risk Management Tools, MS Word, Excel, PowerPoint, Visio, Project and Outlook. Preferred: TOC Analyzer, LCMS-Sciex, Novatek LIMS, ValGenesis VLMS