Quality Assurance Analyst

Job Title: Quality Assurance Analyst, Qualification Facility & Utility

Location: Geel, Belgium

Duration: 10 months (4 FTE)

Company Overview:

Apsida Life Science is currently partnering with a leading global, full-service Contract Research Organisation (CRO) that supports the pharmaceutical, biotechnology, medical device, and consumer health sectors

Responsibilities:

• Review and approve qualification documents & quality records such as SOPs, user requirements, impact/risks analyses, Test Plans, test scripts, change controls, CAPA's etc) to maintain compliance to regulations, guidelines, and company policies and standards.
• Be part of engineering teams and interact with other groups for the introduction of new/upgraded systems and processes. To give advice and support for the preparation of qualification-related activities and guard the cGMP aspects.
• Address and follow-up of deviations occurred during execution of qualification activities.
• Communicate status (quality & compliance, planning) towards J&J QA Qualification team members

Qualifications:

• Experience in the chemical and/or pharmaceutical industry with respect to the qualification of Facility and Utility systems.
• Knowledge of cGMP regulations and guidelines.
• Fluent in English & Dutch (written and spoken)
• Specific know-how of systems
• Facility and Utility systems used within the pharmaceutical or chemical industry.
• Problem report, change request systems. (i.e. Trackwise, Comet)
• Document Management systems (f.e, TruVault)

If you are interested in learning more, please reach out to Sweetness Zono at Apsida Life Science:

Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost-effective, high-quality, high quality and trusted recruitment service that puts the candidate journey at the heart of the recruitment process