Cambrex, a leading global contract development and manufacturing organisation (CDMO) providing drug substance, drug product, and analytical services across the entire drug life cycle, today announced the acquisition of Q1 Scientific – a leading provider of environmentally-controlled cGMP stability storage services for the pharmaceutical, medical device and life science industries, strategically located in Waterford, Ireland.
“Stability storage and testing is a critical component of drug development and commercialisation of new therapies. Q1 Scientific brings world-class capabilities to our ever-expanding portfolio of outsourced pharmaceutical services.”
said Tom Loewald, CEO, Cambrex.
“This acquisition is a natural extension of our current offerings that will broaden and increase our expertise in this critical area, as well as our footprint in the European market.”
Q1 Scientific’s state-of-the-art cGMP facility is ICH validated to meet the specific storage requirements of any pharmaceutical project, with options from -80 C storage up to +50 C, with a full range of humidity control. The 20,000 sq. ft. Waterford facility boasts nearly 40 walk-in stability storage chambers, reach-in freezers and stability units, and ultra-low temperature freezers for biologic therapies. The company also provides sample management and transport services.
Stephen Delaney “We’re pleased to join Cambrex as we continue to provide leading stability storage services to our current customers,”
said Stephen Delaney, CEO, Q1 Scientific.
“With Cambrex’s scientific expertise and scale, we’ll be able to accelerate our growth and offer an integrated suite of analytical services, providing a full range of market-leading solutions for our customers.”
Cambrex offers a variety of storage and testing capabilities with walk-in and reach-in chambers that meet the ICH Q1A requirements. The acquisition will expand Cambrex’s capabilities into the European market.
As pharmaceutical and biopharmaceutical companies continue to seek outsourcing options for non-core capabilities to reduce their footprint, Q1 Scientific’s stability storage services, combined with Cambrex’s industry-leading analytical services portfolio, provide specialised capabilities of high value to the industry.
About Cambrex
Cambrex is a leading global contract development and manufacturing organisation (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 40 years of experience and a growing team of over 2,200 experts servicing global clients from North America and Europe, Cambrex is a trusted partner in branded and generic markets for API and finished dosage form development and manufacturing.
Cambrex offers a range of specialized drug substance technologies and capabilities, including biocatalysis, continuous flow, controlled substances, solid-state science, material characterization, and highly potent APIs. In addition, Cambrex can support conventional dosage forms, including oral solids, semi-solids, and liquids, and has the expertise to manufacture specialty dosage forms such as modified-release, fixed-dose combination, pediatric, bi-layer tablets, stick packs, topicals, controlled substances, sterile, and non-sterile ointments.
For more information, contact us or visit www.cambrex.com
Q1 Scientific provides environmentally controlled, stability storage services for the Pharmaceutical, Medical Device and Food Science industries across Ireland and Europe. Due to expansion we are hiring an Operations Technician to join our team in Waterford.
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.
A typical walk-in stability storage room at Q1 Scientific Our purpose-built facility in Waterford, offers 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.
The Operations Technician role offers the opportunity to build your experience across operations, maintenance and quality. Working as part of a busy Operations team, you will report to our Stability Lead while performing sample management activities.
The role – Operations Technician, Waterford
Operations
Ultra-low freezer storage at Q1 Scientific
Receive and check customer deliveries to Q1 Scientific, highlighting any anomalies and ensure secure, correct and timely storage of such deliveries in line with customer requirements, regulatory and quality guidelines
Take responsibility for retrieval, packing and delivery of samples back to customers
Perform daily checks on stability cabinets/room conditions
Complete equipment calibrations, temperature and humidity mapping (training will be provided)
Ensure the facility is kept clean and equipment and maintenance schedules are maintained as specified by QMS
Liaise with external consultants and contractors
Provide general admin support and any other duties as required
Quality
Ensure that all activities meet the quality standards specified by the Q1 Scientific QMS and in accordance with cGMP standards
Review completed documents for compliance to specification and to ensure all entries are complete
Produce and manage quality reports around deviations
The successful candidate
The ideal candidate will have 2 + years’ work experience in a temperature controlled storage environment (retail or warehouse), manufacturing or pharmacy environment with:
Experience working to standard operating procedures in a regulated environment (this is desirable and not essential)
Previous experience in picking and packing materials
Experience using an inventory management system
You must have:
Good IT skills – email, Microsoft Excel, Word and data entry (essential)
A good work ethic and be willing to work as part of a team or on your own initiative
A positive attitude to work and a willingness to take ownership of projects
Hours of Work
This is a full time, permanent position based in Waterford
Hours of work are 8.30am to 5.00pm Monday – Friday, with the occasional requirement to work outside of these hours
Why join Q1 Scientific?
Now is a good time join us as business growth has been exceptional with a 900% capacity increase over the last 8 years, taking the total unit footprint to 20,000sqft.
In 2020, Q1 Scientific was announced winner of the ‘Contract Services Company of the Year ’ at the Pharma Industry Awards and was shortlisted for the same award last year.
Recently, Q1 Scientific was awarded ‘Business of the Year ‘Entrepreneur of the Year’ at the Waterford Chamber Business Awards.
In addition to a competitive salary, this role offers free onsite parking, benefits and training opportunities.
Apply for the Operations Technician job in Waterford
Send your CV to karrena.legg@q1scientific.com by Friday 27th May 2022.
Q1 Scientific provides environmentally controlled, stability storage services for the Pharmaceutical, Medical Device and Food Science industries across Ireland and Europe. Due to expansion we are hiring a Quality Coordinator to join our team in Waterford.
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.
A typical walk-in stability storage room at Q1 Scientific Our purpose-built facility in Waterford, offers 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.
The Quality Coordinator role offers the opportunity to build your experience across quality. Working as part of a busy Quality team, you will report to our Quality Lead and CEO.
The role – Quality Coordinator, Waterford
QMS
Provision of assistance and advice to the Company on all QMS activities
Ensure that all Q1 activities meet the quality standards specified by the Company QMS and in accordance with cGMP standards
Continually monitors the QMS system suggesting improvements and CAPA measures
Ensure all planned and unplanned changes (deviations) are adequately investigated and documented
Review of completed documents for compliance to specification and to ensure all entries are complete
Proposing/reviewing document changes as appropriate
Maintenance of indexes (electronic and hard copy)
Issue of document numbers.
Providing admin assistance to the Company on all QMS activities issuing controlled documents (logbooks, protocols for execution, etc.)
Proposing/reviewing document changes as appropriate
Working in collaboration with the team members
Audits
Ensure compliance to GMP certification by conducting and reporting internal reviews
Co-ordinates and prepares for all internal, regulatory, supplier and customer audits
The successful candidate
Primary degree in Science
Experience in working in a regulated environment
At least 2 years’ previous experience in QA
Hours of Work
This is a full time, permanent position
Hours are 8.30am to 5pm, Monday – Friday
There is some flexibility around these hours once all operations and opening hours are covered
Why join Q1 Scientific?
Now is a good time join us as business growth has been exceptional with a 900% capacity increase over the last 8 years, taking the total unit footprint to 20,000sqft.
In 2020, Q1 Scientific was announced winner of the ‘Contract Services Company of the Year ’ at the Pharma Industry Awards and was shortlisted for the same award last year.
Recently, Q1 Scientific was awarded ‘Business of the Year
In addition to a competitive salary, this role offers free onsite parking, benefits and training opportunities.
Apply for the Quality Coordinator position
Send your CV to karrena.legg@q1scientific.com
