Quality Systems Specialist

3 weeks ago

Haverhill, United Kingdom Euroapi Full time

**Your Responsibilities**
- Provide vital support to the Haverhill site for all site quality computer systems.
- Provide training and on-going assistance to end users.
- Perform periodic reviews and maintain validation life cycle documentation for site quality computer systems.
- Help maintain quality computer systems in a compliant state, contribute to internal and external audits.
- Identify, and implement continuous improvement opportunities for site quality computer systems
- Uphold the highest standards related to GMP, safety, quality, and validation protocols.
- Support the development of knowledge across the team and promote new ways to work.

This role is a **6 month contract from June - Dec 23 **to provide support for key projects and cover for a seconded employee.

**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 lesElbeuf (France), Budapest (Hungary) and Vertolaye (France).

Our Sales and CDMO teams are present in 11 countries to cover our customers in 80 countries.

The EUROAPI Haverhill (UK) site has been established for 40 years and is located 15 miles east of Cambridge and 60 miles north of London, within the golden triangle. It employs over 250 people and has built a strong reputation in Active Pharmaceutical Ingredient(API) Spray Drying and 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 raredisease medicines supporting global markets. The site is also developing a contract testing and release facility within its laboratories.

**Our Requirements**

Proven experience in working with quality systems and processes in a GxP environment.

Key user experience with QMS, DMS, LIMS or ERP systems and knowledge of GAMP5 would all be desirable.

Excellent written and spoken English skills - you will be working with external and internal stakeholders and working in a regulated industry.

A team focused mindset supporting the broader quality team and organisational goals.

**Your Benefits**
- Hybrid working - requirement to be on site 2 days per week and availability for projects/meetings.
- Contract opportunity from June-December with an attractive rate of pay.

**Culture & Values at Euroapi**

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".

Our values & behaviours are based on the following pillars:

- We empower our people for greater positive impact.
- We create value by putting our clients at the centre of everything we do.
- We are accountable for what we do, always acting with the company’s interest in mind.
- We value and respect all our stakeholders.

**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.

**How to apply?**

**Do you know someone for this role?

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