QA Qualification Engineer - French Speaker (Freelance)

Job Title: QA Qualification Engineer

Location: Verviers, Belgium (Fully On-site)

Contract: 7 Months - Freelance

Hours: 40H P/W

Hourly Rate: €75

Please note you must be able to work in the EU without restriction or sponsorship to be eligible for this role.

i-pharm consulting is working with a global pharmaceutical company who are a preferred global partner to the pharmaceutical, biotech and nutrition markets. They focus on enabling treatments that prevent illness and support healthier lifestyles and optimize scientific innovation and manufacturing technology to enable our customers to serve their patients and consumers. We are looking for a QA Qualification Engineer to join them and participate in projects within the department and with other departments to identify and implement quality improvement projects and policies.

Key Activities:

• Ensure compliance with all applicable cGMP and ISO requirements.
• Ensure 21 CFR part 11 and 21 CFR 820 compliance. Eudralex vol IV annex 1
• Ensure the Qualification and Requalification of a family of Equipment, Utilities
• Ensure the responsibility of a small team. This includes the Training of Personnel, the planning Management, the participation in the elaboration of operating budgets, as well as the daily aspects of a team's life.
• Provide oversight for compliance of CAPA, investigation, OOQ, change control and deviations related to technical issues.
• Maintain compliance of Verviers site to the Quality Systems, applicable regulations, guidance documents, industry standards and customer expectations
• Review and approve and ensure compliance of the GMP Engineering, qualification, maintenance, and calibration documentation: FAT, SAT, IQ, OQ, PQ, Qualification Summary Reports
• Review and approve validations (cleaning validation, process validation …) performed by the MSAT department
• Support as a Subject Matter Expert the execution of the (re-)qualification of thermal mappings of thermal equipment (e.g., freezer, fridge, incubators...) and process equipment (e.g., autoclave) and HVAC systems
• Write qualification/validation protocols (IQ, OQ …) in collaboration with engineering department.

Your Profile:

• Experience in QA qualification for engineering projects
• Background of Engineer
• User of Trackwise platform
• Work very closely with projects Engineers
• Large help in administrative tasks linked to the Quality such as protocols, FAT assistance, preparation of answers & evidence for pre- & post-tasks in Trackwise, etc…
• Full Time On site presence is required.
• Fluent in French and English
• Fundamental understanding of validated computer systems, equipment, sterilization, utilities, process, cleaning, and change management in the pharmaceutical/biotech industry, including training others

Education/Certification

• Master's degree in the field of Engineering
• GMP compliance knowledge including knowledge of 21 CFR Part 11 requirements, GAMP 5, among others.

Work Experience

• 5-10 years' experience in Pharmaceutical, biotechnology or related industry
• 5-10 years' experience in technical projects

If you are interested in finding out more about this role or others, please contact Lia Hamidein at lhamidein@i-pharmconsulting.com or call +44 (0)20 7551 0729.