Your Company –
Scienta is working with a privately held Belgium-based pharmaceutical manufacturing company focusing on the development and formulation of respiratory based products. The Company’s pharmaceutical products aim to improve the treatment options available for patients suffering with asthma and COPD.
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 team, your general responsibilities can be described as follows:
- QA review of project documents and records as necessary; including Control, Review and Risk Management
- 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 Scientific or Engineering degree (or equivalent).
- You have at least ~3-5 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 with the Technical Project Leaders.
- You are pro-active, hands-on, love to solve problems, you like to be challenged, autonomous, out the box thinker and are flexible to work with the suggestions of others in the team.