Innogenetics
Innogenetics NV is a global diagnostic company that develops and markets diagnostic products to improve therapy management and patient health. Innogenetics NV, a daughter company of the Japanese Fujirebio/Miraca group, is based in Ghent. Innogenetics develops and markets a wide range of diagnostic assays with a focus on molecular diagnostics and multiparameter testing. Its products are sold in over 90 countries through its 6 subsidiaries and a large number of distributors.
Quality Assurance officer development & validation
Description de la fonction
The job – Purpose & Baseline
Develop, organise & manage the validation activities within Innogenetics to ensure that in vitro diagnostic products are manufactured in a reproducible & consistent way in accordance to compliance & business requirements
Develop, implement and manage QA methodologies in order to ensure that in-vitro diagnostic test kits, software & automation systems are developed to meet customer expectations & in compliance with current quality & regulatory requirements
The job – accountabilities
Develop and/or oversee validation strategies & its implementation:
The QA officer development & validation has the responsibility to develop or/and oversee validation strategies & ensure that these strategies are translated, implemented & maintained into risk based & compliant procedures.
Organise & manage validation activities to guarantee validated processes during whole product lifecycle
The QA officer development & validation has the accountability to organise & manage the validation activities to guarantee the validated status of all systems, methods & processes at any time during the product lifecycle to ensure product conformance.
Ensure compliance of the design control procedures
The QA officer development & validation contributes to guarantee design control procedures, which comply to all (inter)national standards & regulations through review & approval.
Ensure compliance of product development related documentation
The QA officer development & validation contributes to guarantee design control documentation which complies to all (inter)national standards & regulations through review & approval. It concerns documentation generated during the whole product lifecycle consisting of design development, design qualification, design validation (including diagnostic trials), & post-launch phase.
Profil
• Master in pharmacy, (bio)-engineering, (bio)-chemistry or biology
• 5 years experience in a GxP environment, preferentially in quality assurance in pharmaceutical, biotechnology or medical device industry
• Minimum 5 years of experience with validation in a pharmaceutical/biotech environment
• You have experience in project management and planning
• Knowlegde & understanding of worldwide validation requirements
• User knowlegde of production & QC processes & utilities
• Affinity and experience with the use of diagnostic laboratory instrumentation is appreciated
• Good written and oral communication skills
• Fluent English/Dutch
• Customer-oriented
• Team player : open minded, cooperative, takes initiative
• Organised, accurate, practical
Offre
INNX is an exciting Belgian diagnostic company developing diagnostics to a range of human diseases. Each day you get a chance to contribute, to develop your skills and experience, but also to be part of a young, growing and international environment. INNX currently employs over 220 people in Ghent, Belgium & 60 people in the affiliates.
The working environment at INNX is innovative, focused and with a great deal of independency within the job. You will have the opportunity to work with an outstanding scientific and business team and as such contribute to development of the next generation diagnostic products.
At INNX we strive to provide all our employees the means to develop their skills and experiences, at any level, and this in an environment and atmosphere where having fun at work is a reality. INNX offers a casual yet dynamic environment with continuous development opportunities and competitive salaries and benefits.