K&K Social Resources & Development GmbH is an international recruiting agency that has been providing technical resources in the European region since 1993. This position is with one of our clients in Belgium who is actively hiring candidates to expand their teams.
Role: Computer Systems Validation Consultant
Location: Brussels, Belgium
Employment Type: Full-time permanent
Job Description:
Required
* At least 7 years of Information Technology experience.
* Minimum 3 years’ experience in operating in a pharmaceutical / life sciences / medical device / health technology company as an IT Quality / GxP compliance manager or systems validation specialist.
* Experience performing in project teams and providing deliverables involving the evaluation of IT quality and GxP issues in an FDA regulated environment.
* Evaluating IT risk issues, including the use of data and technology to provide greater coverage, targeted precision and insight.
* Evaluating IT and business controls, including those relevant to GxP, IT quality and 21 CFR Part 11.
* Understanding of common IT risk domains, including cybersecurity, privacy, disaster recovery, change management and IT operations.
* Understanding of the software development lifecycle, including expected controls in an FDA regulated environment and associated computer systems validation.
* Understanding of Corrective and Preventive Action (CAPA) issues management in an FDA regulated environment.
* Performing assessments to evaluate IT controls, security, SOD, and potential for optimization as well as implementation and/or configuration of ERP products.
* Broad understanding of the system architecture, data flow, and key financial and operational processes within a pharmaceutical, life sciences, CRO, or medical device organization.
* Candidate must be located within commuting distance of Brussels area or be willing to relocate to the area.
Responsibilities:
* Discussing with project stakeholders for validation planning and scheduling, Risk assessment, assessing GAMP category
* Responsible for defining and Authoring validation strategy and validation summary reports for GxP and non-GxP IT systems
* Review & approve CSV deliverables as a Validation specialist i.e. user requirements, system specifications, Risk assessment, Validation plan, Qualification plans, SOPs, IQ/OQ/PQ, Traceability matrix, Design Specs etc.
* Validate IT systems used by our life sciences client
* Define Project Documentation List
* Author Validation Plan, Validation Report, and review other system deliverables such as URS, FS, CS/DS, IQ, OQ, PQ, FRA, Test Strategy Plan / Report
* Ensure data migration is executed in a controlled manner; execute Data Migration Plan / Report
* Support operational activities such as Change Management, Deviation Management, Periodic Reviews, Retirement, Audits / Inspections
* Ensure stage gates are adhered to as per client’s project management methodology
* Provide input on project progression / status to the management team on a periodic basis
* Flag issues / concerns / challenges related to system validation and operational activities
Note: Applicants for employment in Belgium should possess work authorization which does not require sponsorship by the employer for a visa.