Qualified Person

Posted 13 Days Ago
Be an Early Applicant
Haverhill, MA
Mid level
Healthtech • Pharmaceutical • Manufacturing
The Role
The role involves certifying and releasing drug products, ensuring compliance with regulations, and collaborating with various teams on manufacturing processes and complaints.
Summary Generated by Built In

Are you a Qualified Person looking for a role releasing packed batches for secondary operations and certifications for spray dried intermediates for a CDMO business? You will conduct lab investigations and provide certifications for semi-finished products, blisters, vials & steriles. Apply today!

Your Responsibilities    

You will: 

  • Ensure compliance within the Haverhill operation in line with the requirements of the manufacturing licence.
  • Proactively develop your knowledge on a continued basis in areas such as dosage forms, manufacturing processes and the relevant cGMPs and seek to develop and coach others.
  • Develop a deep technical and professional knowledge of all the relevant company processes and quality management systems in respect to upstream manufacturing activities to ensure you can certify and release finished investigational drug products.
  • Collaborate with Manufacturing and Regulatory Affairs to provide support for license submissions and review the CMC requirements to ensure correct distribution practices.
  • Provide guidance and work with Senior Leaders to resolve complaints, deviations or product recalls ensuring best practice across the site.  

Our Company    

EUROAPI is a new player in Active Pharmaceutical Ingredients (API), carve out from Sanofi with the purpose of becoming a worldwide champion in API commercial and Contract Development and Manufacturing Organization (CDMO) activities.  

Taking action for health by enabling access to essential therapies inspires our 3,350 people every day. Headquartered in Paris, Euroapi include 6 European API production sites located in Brindisi (Italy), Frankfurt (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Budapest (Hungary) and Vertolaye (France).    

The EUROAPI Haverhill (UK) site has been established for forty years, located fifteen miles east of Cambridge and sixty miles north of London, within the golden triangle. It employs over 250 people and has built a strong reputation in Flow Chemistry, Active Pharmaceutical Ingredient (API) Spray Drying and as a Contract Development and Manufacturing Organisation (CDMO). Haverhill is proud to house the world’s largest, continuous production, pharmaceutical spray dryer and performs secondary packaging and release activities for oncology and rare disease medicines supporting global markets. The site also offers a contract testing and release facility within its laboratories.   

Our Requirements    

You will be eligible to act as a QP in the UK.

You will have experience working in biologics, sterile drug manufacturing, solid dose or vaccines.

Knowledge of spray drying processes would be beneficial. 

Full time (36 hours per week)

Your Benefits   

  • Attractive Salary
  • Competitive benefits
  • Training & Development 
  • 36 hours per week, 9-5.30pm Monday to Thursday, 9-4pm Friday
  • Onsite subsidised restaurant

Culture & Values 

We bring our culture to life in the way we work every day. Our culture enables career development and talent management, we recognise that how we do things is as important as what we do, and our values set out how we achieve our goals and help us "do it right". 

Diversity & Inclusion  

EUROAPI is committed to nurturing a culture of diversity and inclusion that contributes to improving innovation, performance, and engagement. We value transparency, mutual respect, and equal treatment of people. For this reason, we are firm in protecting our employees against any forms of discrimination.  

Environment, Social and Governance   

We strongly believe that the success of our company lies in its capacity to adapt to tomorrow’s challenges. Our responsibility as a company is to provide sustainability and resilience to the pharmaceutical value chain. 

Apply Today!   

Find out more about this exciting opportunity, apply today or contact Marie Meekings.

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The Company
Bridgewater, , New Jersey
1,540 Employees
On-site Workplace
Year Founded: 2021

What We Do

EUROAPI is focused on reinventing active ingredient solutions to sustainably meet customers’ and patients’ needs around the world. We are a leading player in active pharmaceutical ingredients with approximately 200 products in our portfolio, offering a large span of technologies, while developing innovative molecules through our Contract Development and Manufacturing Organization (CDMO) activities.

Taking action for health by enabling access to essential therapies inspires our 3,450 people every day. With strong research and development capabilities and six manufacturing sites all located in Europe (Saint-Aubin-lès-Elbeuf and Vertolaye in France, Brindisi in Italy, Frankfurt in Germany, Budapest in Hungary and Haverhill in the UK), EUROAPI ensures API manufacturing of the highest quality to supply customers in more than 80 countries.

EUROAPI is listed on Euronext Paris.

OUR VISION
Reinventing active ingredient solutions to sustainably meet clients’ and patients’ needs around the world in a sustainable way.

OUR MISSION
We work passionately every day to develop, manufacture and supply active-ingredient solutions for our healthcare partners around the world.
We combine our scientific excellence with industrial expertise and a wide range of technologies to deliver solutions that meet the highest quality, social and environmental requirements - all while ensuring stakeholder satisfaction.

OUR FUNDAMENTALS
We are driven by the success of our clients and their satisfaction

* Reliability *
EUROAPI is the leading small molecules API player with an unique European industrial platform and proven track record for reliability.

* Quality *
EUROAPI provides you with active ingredients that meet the highest pharmaceutical standards.

* Premium Client Service *
EUROAPI manufactures your success through tailored solutions and a long-term partnership approach that provides peace of mind

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