Computer Systems Validation
hace 5 meses
About the Role:
The CSV Analyst will play an integral role in ensuring that IT managed GxP computerized systems and infrastructure, are validated or qualified in accordance with corporate quality standards.
Duties and Responsibilities:
The CSV Analyst will oversee GxP impacting projects to ensure that all applicable regulatory and compliance requirements are met for any new or revised computerized systems to ensure that these systems are not only defendable during an inspection, but also confirm that the delivered systems/services are fit for purpose by meeting user requirements.
Your Contributions (include, but are not limited to):
Implementation Projects
Evaluate proposed new computerized systems or software to assess GxP impact and where GxP impact is identified provides guidance on the risk-based validation approach for the system Work closely with the Project manager to ensure all compliance milestones are met during the project lifecycle. Oversee and/or assists in the development of validation deliverables including Validation Plans, Test Plans/Protocols/Scripts, Specifications and Design Documents, Compliance Assessments, Risk Assessments, Installation Qualification, System and User Acceptance Testing, Data Migration Plans, Traceability Matrices, Validation Reports, Supplier Assessments, etc. Prepare, or review and approve major system documentation to ensure consistency with quality standards and quality of deliverables. Establish and maintain standards and training materials for the specification, design, development, configuration, implementation, validation, use and maintenance of computerized systems which support the development, manufacture and distribution of products in alignment with applicable company policies and regulations. Coach the implementation teams in the proper execution of validation documents Manage formal testing of computerized systems including, setup of testing, documentation, approval, delivery, and test reporting. Solve problems during validation process and address/advise on issues such as deficiencies, deviations, and change controls. Ensure initiation/preparation and closeout of all CSV related deviations. Supply accurate KPIs to management on Project compliance statusSystem Maintenance
Review proposed changes to validated computer systems/qualified IT infrastructure and identify the validation or qualification requirements necessary to maintain the validated/qualified state after execution of the change. Ensure all changes are implemented and documented in a compliant manner. Perform periodic assessment to review and confirm validated status. Perform periodic re-validations.Quality Management
Ensure initiation/preparation and closeout of all CSV related deviations, discrepancies and change control documents. Conduct Quality Reviews to evaluate if processes and deliverables fulfil the requirements for quality, to uncover errors or deficiencies in processes and deliverables, and to identify strengths and opportunities for improvement. Follow up resolution of identified quality exposures and escalation to team lead if critical situations are not resolved in due course. Ensure that suppliers of IT services and solutions are properly assessed to determine their level of competence and reliability, and ensure the organization employs appropriate risk based approaches to delivery taking into account the output of the supplier assessment. Maintain up to date knowledge of evolving regulatory requirements, availability of current/new techniques, and literature regarding compliant computer systems, and acts as an information resource for the delivery teams and wider business.About You:
Education/Qualifications:
Strong understanding of GXP Regulatations and best practice (21CFR820, 21CFR11, Annex 11, GAMP, etc.) Demonstrated experience in successfully managing complex validation projects and maintaining the validation requirements for computerized systems supporting healthcare products. Detailed understanding of computer system validation and infrastructure qualification, including the application of risk managed approaches. Experience in electronic software applications such as Electronic Document Management System (EDMS), Product Lifecycle Management (PLM), Quality Management Systems (eQMS), Complaint Management Systems, Enterprise Resource Planning systems (ERP), etc. Ability to rapidly adapt to new situations and environments. Excellent communication skills with the ability to effectively convey compliance requirements at all levels. Ability to influence, negotiate, and constructively challenge to achieve productive solutions. Ability to handle a high concentration of work through successful multitasking & prioritizing. Conscientious and highly committed, with a dedication to quality. Bachelor’s degree in computer science, engineering life science or related field plus 2 years experience with CSV validation lifecycle management, and validation documentation development. 2 plus years of pharmaceutical manufacturing or Medical Device industry experience in computer systems validation, process validation, QA or compliance functions. Excellent understanding and experience with industry regulations, standards, and guidelines, , GxP, validation, 21 CFR Part 11, etc. Excellent presentation and writing skills.Travel: 10%
Working conditions: Hybrid
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Equal opportunities
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.
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