CSV Analyst

Responsibilities

• Computer Systems Validation Leader / Manager is responsible for Quality oversight and management of Computer System Validation (CSV) in accordance with industry standards and regulatory guidance.
• This is a hands-on oversight role that will be accountable for ensuring that Client’s computer systems are appropriately validated before release and remain in a compliant state throughout their life. This position requires a broad range of knowledge and a deep understanding of various rules and regulations as well as international standards and guidelines.
• Maintain CSV and Computer System Change Control processes

• Apply risk-based methodologies in the oversight of Computer validation and Instrument System qualification efforts
• Provide leadership and guidance to personnel on CSV matters and ensure compliance to applicable industry regulations
• Maintain CSV templates
• Conduct GxP evaluations of new Computer and Instrument Systems
• Work collaboratively across functions with Quality, IT, Business partners, and Vendors to plan, coordinate, and execute CSV activities
• Review CSV lifecycle documentation from a Quality perspective and approve as Quality representative
• Oversee formal test execution to ensure the testing was performed appropriately and the test results are compiled in a timely manner
• Review and approve System-specific Administration and User SOPs
• Oversee the readiness of the CSV program to ensure Computer Systems are compliant and ready for regulatory reviews
• Be the QA CSV Subject Matter Expert (SME) in support of audits and regulatory matters
• Provide guidance and direction throughout the GxP Computer and Instrument System Change Control process
• Ensure appropriate standards and practices are implemented for the collection, use, transfer, storage, and deletion of personal information in GxP Computer and Instrument Systems
• Perform Quality oversight and approval of periodic user access review
• Ensure CSV lifecycle documentation is completed and filed appropriately
• Maintain and present applicable metrics and key performance indicators
• Review of application vendor's qualification and/or validation documentation, as applicable
• Work with vendors for change control management, incident management and issue resolution
• Proactively identify and collate information required to assess compliance with processes and prioritize business process improvement needs.
• Review, assess and update procedural documents for overall compliance with current processes, as required
• Proactively collaborate with initiative leads and senior management to develop, optimize and improve CSV processes, training, and communications
• Perform special projects, assignments, and administrative tasks per business needs
• Provide guidance and review or create varied support materials, presentations, and/or tools to support department's remit and strategies.
• Mentor, coach, and support team members
 

Education and Experience
• 10+ years of experience working in electronic based Computer System Validation in a GxP environment
• Demonstrated ability to maintain a CSV and Computer and Instrument System Change Control process
• Experience in employing risk-based approaches to CSV • Experience in qualification of GLP Instrument Systems
• Ability to provide Quality oversight during implementation of GxP Software as a Service tools and systems
• Experience in performing validation of cloud-based Computer solutions
• Significant experience in authoring, reviewing and execution of validation and qualification documents, including test scripts.
• Project management experience for regulatory projects
• Knowledge of practices and procedures of the full software development life cycle
• Strong attention to detail
• Hands on experience with eDMS tools like Documentum or Master Control, as well as testing tools like Jira, ALM, etc.
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification or previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
• GAMP, GxP and VLMS/eDMS application training (desirable)

Desirable Knowledge, Skills, and Abilities
• Strong knowledge of software development lifecycle, GAMP and CSV processes
• Working knowledge of GxP, FDA, EU and other relevant regulatory requirements for Pharma, Biotech, and med devices.
• Ability to develop/update validation project plans and computerized system lifecycle program documents to deliver large CSV projects

• Significant experience in authoring, reviewing and oversight of the execution of CSV documents, including Validation Plan, functional and regulatory risk assessments, • • • • • User/Functional/System/Data Migration Requirements, IQ/OQ/PQ protocols, test plans, test scripts and test reports, traceability matrices as well as Validation Reports.
• Hands on experience with common tools and processes within the digital validation arena (Jira, ALM, Master Control, Documentum, First Doc, TX3, Kneat, ValGenesis, etc.)
• Understanding and experience with automated testing, including tools like Tosca and Leap Work (desirable)
• Good knowledge and experience with maintaining the validated state, including Change Management, CAPA, audits, etc.
• Strong problem-solving, verbal, written and presentation skills
• Computer literate with the ability to work within multiple databases
• Proficient in Microsoft Office products (including Outlook, Word, and Excel)
• Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision
• Ability to maintain a positive and professional demeanor
• Ability to work effectively within a team to attain a shared goal
• Project management experience