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Job ID :
63364BR
Location :
United Kingdom - Swindon
:

About Us

Contract Development and Manufacturing in pharmaceuticals is growing fast. Patheon now Part of Thermo Fisher Scientific, with almost $2 bn in revenue last year, is at the top of the tree.  We offer our clients an unrivalled mix of technologies, taking their products from the earliest stages of development through to becoming the world-beating medicines of today and tomorrow. 

As a new member of the Thermo Fisher Scientific family, we are part of the world leader in serving science.  And with over $20 billion in annual revenue and 65,000 employees, this is the place to be for ambitious people.

Our Swindon operations offers full commercial manufacturing services for sterile liquids, high-potency products, as well as lyophilized vial forms. We champion the ‘Condo Model’ and manufacture speciality products for clients; offering an impressive mix of laboratory, business and production expertise. Because of this unique offering, we are experiencing huge growth as new clients join us.

This exciting partnership between Patheon and Thermofisher has created a driving force in the research, healthcare, industrial and applied markets. No other company can match our range of customer touch points—technologically, geographically or commercially. We help customers in finding cures for cancer, protecting the environment, making sure our food is safe and moving forward with thousands of important projects that improve millions of lives.

About the job

This is an exciting opportunity to join us as the Subject Matter Expert for Quality Risk Management (QRM) across the site. You will define, promote and own the site guidelines and standards for GMP Quality Risk Management Process, including but not limited to; quality of products, processes, facilities, utilities, equipment, analytical and test method.

Your role will be vital to new product introduction as new Condo clients join us. Partnering with our clients; you will be a key player in understanding their processes and leading on the design of the Quality Risk Management Process. Collaborating with colleagues across the broader Quality team, project management, engineering and production to analyse, evaluate, mitigate and control risks in line with international standards and our Quality Management System. 

Once these processes are implemented you will still remain involved through conducting periodic risk reviews; reviewing, approving and  supporting any Investigation, Deviation or Change proposals that may have a QRM impact. Keeping the site Quality Director and Condo clients up to date at all times.  

About you

We are looking for people who are passionate about making a difference in people’s lives. People who are motivated to do their best for the company, our clients and our patients – and to inspire collaboration and innovation. 

Alongside this you will have a science based degree with experience working in a pharmaceutical quality function, preferably sterile manufacturing. As you will be our Risk Subject Matter Expert we will expect you to have a deep understanding of implementing ICH Q9 principles, methods and tools working within EU/US GMP regulations and familiar with the following Risk Management tools: FMEA, FMECA, HACCP and FTA. In other words you have the technical drive and confidence to represent Patheon when dealing with our Condo clients.

In return you will discover resources that match your personal development interests, a culture that welcomes your ideas and opportunities in a way that only a global leader can. And an opportunity to be working alongside enthusiastic colleagues who a dedicated to making a difference to the world.  Come join us to make a difference too. 

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