Computerized Systems Validation Specialist

Groupe PARIMA is a Contract Development and Manufacturing Organization (CDMO), established in 1994. For over 30 years, we have developed an expertise in the development and manufacturing of non-sterile liquids, suspensions and semi-solid drug products. https://www.groupeparima.wp.vortexdev.com/fr/

Computerized Systems Validation SpecialistResponsible for the Computer Systems Validation Master Plan.

Responsabililities:

• Develop and review computerized systems validation deliverables and supporting documents following a risk-based approach to patient safety, product quality and data integrity in consideration of FDA 21 CFR Part 11, 210 and 211 and Part C, Division 2 of the Canadian Food and Drug Regulations.
• Write and review applicable risk assessments and test scripts according to GxP and program-policies
• Participate in change control assessments and updates of validated systems.
• Participate in audits or client requests as the CSV SME.
• Supports consultants and review external deliverables
• Support Analytical Instrumentation software validation
• Search and obtain archived documents and manage archived documentation applicable to GxP computerized systems
• Create templates and perform review of audit trails for IT GMP systems
• System Periodic Review and identify, execute and resolve system gaps
• Research feasibility and alternative IT solutions
• Provide project status Experience and competencies required:
• Bachelors degree in Science, Engineering or Computer Science or equivalent industry experience.
• Strong understanding of GxP and 21 CFR Part 11
• Strong understanding of Computerized System Validation Concepts and GAMP 5
• Capability of managing multiple projects
• Good organization and documentation skills
• Proficient English Writing Skills
• Strong understanding of business processes in a regulatory environment What we offer :
• Medical, dental and travel insurance
• Group pension plan
• Recognition program and social activities
• Personal leave
• Employee support program and telemedicine
• Free beverages (hot chocolate, coffee, mochaccino)
• Accessibility by public transit or free parking
• Referral program
• Subsidized meal program