Client is seeking a Computer System Validation Leader experienced in Life Sciences GxP software validation.
Responsibilities
Computer Systems Validation Leader / Manger 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 Client / Client 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
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