Ingénieur Assurance Qualité Environnementale H/F

Ingénieur Assurance Qualité Environnementale H/F at AbbVie in Annecy, Auvergne-Rhône-Alpes, France.

Responsibilities

You bring us your ability to

• Provide support for the site's strategic projects (operation and R&D) and production improvement projects. You guarantee compliance with the group's standards for own production/utility areas.
• Participate in Change Control as environmental technical support as well as technical reviews of (QIQO)QP protocols and reports, as well as associated deviation sheets.
• Ensure a link with the production, CQEM (environment and microbiology) and CQS (support) teams for monitoring information on project activities.
• Write Change Requests for creation/modification linked to projects for the control points present in the LIMS (laboratory analysis results management software).
• Participate in the definition of the strategy and methods for cleaning activities of premises and cross-contamination.
• Provide training for dressing in the production area.
• Participate in ZAC or utility environmental audits (internal/external), write responses to the audits and make the expected improvements.
• Establish technical risk removals for non-compliances for ZACs (Controlled Activity Zones) and for Critical Utilities.
• Implement the corrective actions and improvements expected within the framework of internal/external/non-compliance audit

Requirements

What you need to know about us

• Join us by integrating the 3rd largest pharmaceutical laboratory in the world and a growing site between lake and mountains!
• Leader in medical aesthetics, Allergan, a subsidiary of the Abbvie Group, develops and manufactures sterile injectable products based on hyaluronic acid, for the aesthetic treatment of the face, thus contributing to the well-being of patients.
• Our ambition? Offering the best innovation in the aesthetic medicine market.

As part of a replacement, we are recruiting for our Quality department, based in our center of excellence for aesthetic medicine in Annecy, Haute-Savoie:

An Environmental Quality Assurance Engineer on a fixed-term contract

Under the responsibility of the site Environmental Expert and the Quality Assurance Manager, you act as an expert to provide quality support on environmental issues related to clean rooms (ZAC) and site utilities.

You have the assets to join us

• Higher education Bac+5 such as Master, Engineering School or Pharmacy specialized in Quality
• 5 years of experience in the pharmaceutical or medical device field
• Experience working in production areas (clean rooms) and knowledge of utilities
• Good knowledge of cross contamination
• Mastery of GMP Quality standards and ISO 13485, ISO 14644, EN 17141
• Practice of professional English (written and oral)
• Mastery of office tools (MS Word, Excel and PowerPoint)
• Autonomy and rigor
• Method and precision, as well as a spirit of analysis and synthesis
• Be a force of proposal and initiative
• An ability to adapt and be open to change

Benefits

• All your information will be kept confidential according to EEO guidelines.
• AbbVie is an equal opportunity employer committed to acting with integrity, driving innovation, transforming lives and serving our community. Equal opportunity employer for veterans and people with disabilities.

About the Company

AbbVie's mission is to discover and produce innovative medicines that provide solutions to today's serious health problems while meeting tomorrow's medical challenges. We seek to transform people's lives across several key therapeutic areas including immunology, oncology, neuroscience, ophthalmology, virology, in addition to products and services within our Allergan Aesthetics portfolio. We are proud to be a Great Place to Work company.