R&D Quality Assurance Engineer M/F

Role Summary

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 R&D department, based in our center of excellence for aesthetic medicine in Annecy, Haute-Savoie:

A R&D Quality Assurance Engineer on permanent contract

This mission will suit anyone wishing to evolve within a multicultural organization combining agility, commitment and speed of action.

A true quality partner of R&D teams, you support new product development projects and help ensure compliance of activities with internal, regulatory and normative requirements, throughout the product life cycle.

Responsibilities

As such, you will be required to

• Support the R&D teams in the implementation of the design control process: you contribute to the preparation, review and approval of product development quality deliverables.
• Participate in design reviews, analysis of needs and specifications, as well as monitoring of design modifications after transfer.
• Write and approve the deliverables of the design files as well as the resulting quality documents (e.g. specifications, protocol and R&D stability reports, etc.).
• Ensure product compliance through the risk management process throughout the product life cycle
• Ensure that risk analyzes are updated in relation to non-compliance processes, changes, design changes, post-production monitoring by planning and leading update committees.
• Contribute, with partners to the implementation of means to guarantee an acceptable level of risk
• Coordinate and carry out quality actions relating to the control of R&D premises (approval of system documents)
• Ensure that the necessary corrective and preventive actions following non-compliance are implemented, monitored and their effectiveness verified
• Support investigations when there is a problem to resolve

Deploy the quality culture with our partners as a quality representative in projects.

Requirements

You have the assets to join us

• Higher scientific training (pharmacist or engineer or PhD) with significant experience in an industrial environment, in medical and/or pharmaceutical devices
• A minimum of 5 to 8 years of experience in product development and R&D project management
• Mastery of risk analysis and Design Control tools and standards
• Solid knowledge in cleaning and contamination validation
• Knowledge of quality and regulatory requirements applicable to medical devices and/or combined products, in Europe and the United States
• Mastery of applicable general quality requirements (design, quality system, sterilization, purchasing, environment, etc.),

Mastery of office tools (MS Word, Excel and Power Point).

• Fluency in English at level B2 is essential
• Autonomy and team spirit
• Ease and editorial rigor
• The ability to respect commitments
• Excellent written and oral communication
• Rigor / method / precision / a capacity for analysis and synthesis
• Sense of responsibility

Benefits

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

About AbbVie

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.