Method Validation & Quality Control Specialist
Created in 2013, Wishbone is an innovative start-up located in Flemalle (Liege). Wishbone is engaged in the development of intraoral bone regeneration biomaterials. The company is launching its industrialization and production activities in a brand new production unit.
The goal of Wishbone is to develop superior bone graft substitute products with breakthrough technologies and innovative procedures, and thus improve patient well-being and contribute to a better environment. For more information please visit: www.wishbone-biotech.com
To support this challenging development, we are looking for a (m/f): Method Validation & Quality Control Specialist
As a Method Validation & Quality Control Specialist, you are responsible for the analytical method development and for the product analysis. You manage multiple projects in line with a product portfolio, regulatory requirements and products quality control.
Your main responsibilities are:
- Develop and apply analytical methods (including validation) and select adequate techniques and equipment.
- Ensure product release based on quality standards and an analytical method follow-up.
- Perform and document a product file including the design and development phases, the verification and validation phases.
- Conduct and document on and off-site product testing to determinate compliance with applicable international standards and regulations.
- Evaluate the risk associated with products and design the test plan.
- Prepare, write and revise regulatory files for CE marking of Wishbone product range.
- Master or PhD in Biotechnology, Chemistry, Bioengineering or any related field.
- 2 years of experience in analytical and characterization methods.
- Experience in surface analysis and biomaterials characterization is a strong asset.
- Knowledge of GMP and quality standards (ISO 13485, GLP).
- Ability to work in a start-up environment where accuracy, accountability, quality, safety and timeliness are essential.
- Highly collaborative, self-motivated and team-oriented individual in a company setting.
- Excellent oral and written communication skills in English. Any other language is an asset.
- The opportunity to join an innovative medical device company, a fast-growing start-up environment where teamwork, achievements and patient care are very important.
- A challenging and diversified position in a dynamic, young and professional environment.
- Working in a human size, dynamic, respectful and professional environment.
- An attractive compensation package in line with the position responsibilities and your experience.
Please send your CV together with an adapted cover letter http://www.pahrtners.be/job/method-validation-quality-control-specialist/.
Your application and related information will remain strictly confidential.