QA Engineer
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Gent • Belgium
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About the role
- Provide quality oversight for computer system validation activities in accordance with Janssen policies
- Act as Process Owner for Computer Systems Validation management
- Review and approve CSV documents such as SOPs, user requirements, risks analyses, Validation Plans, tests, changes, deviations
- Maintain a current knowledge of international laws, guidelines related to CSV
- Prepare for computer system audits and inspections
- Cooperate with engineering, IT and other teams for the introduction of new systems and processes
Requirements
- Master scientific degree or equivalent experience
- 3 years’ experience in the pharmaceutical industry
- Knowledge of cGMP/CSV compliance (21 CFR Parts 11, 210, 211; EU Directive 2003/94/EC and annex 11; GAMP, Data Integrity Guidelines)
- Experience with Computerized System Validation
- Strong ownership and quality attitude
- Ability to make risk-based decisions
- Fluent in verbal and written communication in English and Dutch.
Benefits
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
computer system validationSOPsuser requirementsrisk analysesvalidation planstestingdeviation managementcGMP complianceCSV compliancedata integrity
Soft skills
quality oversightownershiprisk-based decision makingcommunication
Certifications
Master scientific degree