Due to international expansion, we are hiring a Quality Coordinator to join our team in Belgium. This is a key hire for our new Belgium site located in Villers-le-Bouillet, Belgium. With ambitious growth targets, this is an exciting opportunity to join Q1 Scientific in Belgium, where we serve pharmaceutical and medical device companies across Germany, France, and the Netherlands.
Q1 Scientific provides environmentally controlled, stability storage services for the Pharmaceutical, Medical Device and Food Science industries across Ireland and Europe. Our purpose-built facilities offer walk-in rooms and reach-in cabinets for sample storage at specific temperature and humidity conditions ranging from ultra-low freezers at -80°C to storage over 50°C.
Through our support of international pharmaceutical and medical device companies, we very much see Q1 Scientific as being part of a customer’s own operational and production chain. The healthcare products provided by these companies are vital and we are privileged to perform our part in the provision of those products to the global market.
The Quality Coordinator role
As the Quality Coordinator, you will report to the General Manager while coordinating quality activities and providing support to Operational functions. Specific responsibilities include but are not limited to:
Quality Management System
- Provision of assistance and advice to the company on all Quality Management System (QMS) activities.
- Ensure that all Q1 activities meet the quality standards specified by the Company QMS and in accordance with cGMP standards.
- Continually monitor the QMS system suggesting improvements and CAPA measures.
- Ensure compliance to GMP certification by conducting and reporting internal reviews.
- Co-ordinates and prepares for all internal, regulatory, supplier and customer audits.
Administration of quality documents, continuous improvement initiatives and interaction with management personnel on quality issues to include but not limited to:
- Providing admin assistance to the Company on all QMS activities issuing controlled documents (logbooks, protocols for execution, etc.).
- Maintenance of indexes (electronic and hard copy)
- Issue of document numbers.
- Review of completed documents for compliance to specification and to ensure all entries are complete.
- Proposing/reviewing document changes as appropriate.
- Checking off second signature for Stability Lead as appropriate.
- Performing daily checks on stability cabinets/room conditions as appropriate (in the absence of the Stability Lead).
- Providing support as required for checking of samples on receipt at Q1 Scientific/on return to Client as appropriate.
- Providing general admin support as required.
Requirements for the Operations Lead role
- A minimum of 3 years experience performing a similar role within a regulated industry (pharmaceutical or medical device industry experience is preferred)
- Primary degree in science
- Previous experience in QA and working with QMS.
- Good IT skills
- Fluent in French and English
Hours of work
- Normal office hours are from 8.30 am to 5 pm, Monday to Friday
- There is some flexibility around these hours once all operations and opening hours are covered
- The Q1 Scientific office is located in Villers-le-Bouillet, Belgium
Why join Q1 Scientific?
Now is a good time to join us as business growth has been exceptional with a 500% capacity increase in Waterford over the last 9 years, taking the total unit footprint to 30,000 sq ft. During the first half of 2023, Q1 Scientific is opening a new 20,000 sq ft cGMP facility in Belgium. As the Stability Lead, you will play a key role in growing our new Belgium site.
In 2020, Q1 Scientific won ‘Contract Services Company of the Year’ at the Pharma Industry Awards and was shortlisted for the same award in 2021. Last year Q1 Scientific was awarded ‘Business of the Year‘ at the Waterford Chamber Business Awards.
Q1 Scientific was acquired by Cambrex in June 2022. Cambrex is a leading global CDMO that provides drug substance, drug product and analytical services across the entire drug lifecycle. Cambrex’s team of over 2,200 experts has over 40 years of experience serving global clients from sites in North America and Europe. Thanks to the range of career prospects at Cambrex, there are plenty of opportunities to develop new skills and progress your professional development.
In addition to a competitive salary, this role offers free onsite parking, benefits and training opportunities.
To apply, please send your CV to email@example.com.