QA Expert

The Company –

Scienta is teaming up with a privately held Belgium-based respiratory company focused on the development of combination products.

The Company’s pharmaceutical products are poised to change the treatment paradigm in large markets including asthma and COPD. Their products, to be used for pharmaceutical development and approval processes, are innovative as well as cost optimised.

Main responsibilities –

Together with the other QA colleagues you’re responsible for QA review of external documentation supporting activities related to pharma, to ensure adherence to applicable regulatory GxP guidance.

Working closely with the R&D Scientists and Engineers, your tasks can be described as follows:

Document Review:

• QA review of project documents and records as necessary; including Design Control, Risk Management, Design Review.
• QA review of vendor project documents and records as necessary; including protocols, reports, methods, validation, and batch records.
• Quality oversight of vendor data investigations; including Out of Specification (OOS) and Deviation management.
• A Quality function signatory on external project documents.

Vendor Compliance Monitoring:

• Preparation of Quality materials for Project team meetings.
• Maintenance, compilation, and analysis of Vendor Quality metrics.

Supporting work in the following area:

• Maintenance of company certifications.
• Continuous Improvement (CI) of the documents and systems of the QMS.
• Preparation and reporting of external audits.
• Establish Pre-Approval Inspection (PAI) readiness at strategic commercial partners.

Your Profile –

• You have a science or engineering degree.
• You have at least 5 years’ experience in a Quality role in the related area.
• You have drug product experience.
• Good knowledge of GMP is essential.
• You are fluent in English, both written and spoken
• You are keen in working in an international environment, willing to occasionally travel to vendors.
• You are pro-active, hands-on, love to solve problems, you like to be challenged, autonomous, out the box thinker.