VIE - Quality Assurance Coordinator - Bridgewater, United States - EuroAPI

Description

We are looking for a VIE - Quality Assurance Coordinator for a VIE contract of 18 months in our US site in Bridgewater to support its activity.

Before applying, please make sure to check the VIE eligibility criteria for the United States and add your resume in English to your application.

Your responsibilities:

Customer Request & Complaints:

• Collect, handle and follow-up on customer QA requests and complaints,
• Coordinate investigation work on deviations and non-conformities in cross-functional teams,
• Initiate and assure the follow-up of open CAPA (Corrective Action Preventive Action)
• Review batch records in accordance with release requirements
• Review validation documentation (Production, Quality Control...)
• Support change control and its implementation

Quality Management Framework:

• Participate in the continuous improvement of the Quality Management Systems
• Help write and assess APR (Annual Product Review) and QPR (Quality Performance Review)
• Ensure compliance of product shipments with regulatory standards (FDA, EMA, ICH, ISO...)
• Ensure proper recording of all QA activities in global tracking & reporting systems

Your profile:

• Master's degree in Quality Management, Quality Engineering or Regulatory Affairs
• 2-3 years of professional experience (experience in pharma is a plus)
• Good understanding of Global Quality & Good Manufacturing Practices (GMP) standards
• Basic understanding of North America Health Rules & Regulations (ex: FDA guidelines)
• Strong data analytics skills and ability to manage large volume of information
• Excellent project management skills and analytical skills
• Demonstrates ability for teamwork and interaction with multiple stakeholders
• English is mandatory and French is a plus

Our Company

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-ls-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.

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".

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.