Offre d'emploi : QUALITY ASSURANCE MANAGER
TEXERE BIOTECH builds forefront automated lines for processing human tissues, based on A.I. and robotics. More specifically, this start-up company currently offers fully robotized processing services to bone banks.
Created in 2016, TEXERE BIOTECH’s innovative technology is already recognized as a revolution in the field! The company’s first 100% Walloon line produces bone grafts, from human skeletal to the final product’s packaging.
Backed by Sambrinvest and the Walloon Region, TEXERE BIOTECH shows great development ambition in terms of business and technology. For additional information about the company, please visit https://www.texerebiotech.com/.
To strengthen the team in Frasnes-lez-Gosselies (North of Charleroi), we’re looking for an (m/f)
QUALITY ASSURANCE MANAGER
Reporting to the Human Body Manager, you set up a Quality Management System (QMS) and manage all QA activities within the organization. You ensure the compliance to Texere Biotech’s QMS and to Human Body Material (HBM) rules in every operational activities.
Your main responsibilities are to :
- Implement an efficient QMS and a continuous improvement culture within the company.
- Ensure that required QMS processes are documented, established and maintained.
- Analyze deviations and follow-up with Corrective Actions/Preventative Actions (CAPA).
- Supervise batch records in order to release Texere Machined Bone Grafts batches.
- Support, train and advice teams on QA activities or issues.
- Participate in internal/external audits, inspections and provide post-inspection follow-up.
- Select suppliers and subcontractors in accordance with the COO and HBM Manager.
- Write and update SOP, work instructions, and policies.
- Report to the management on the QMS’ effectiveness and on the company’s needs for improvement.
- You hold a Master or PhD in (Bio) chemistry, Biotechnology, Physics, Pharmacy, Engineering or equivalent by experience.
- You show at least 5 years’ experience in a QA management positions in biotech/pharma environments.
- You possess a good knowledge of Human Body Materials, command of GMP rules is a strong asset.
- You have an excellent command of English (oral and written), French is a plus.
- You are both autonomous and a team player with an inquisitive mindset.
- You are results and solutions oriented with a pragmatic mind-set.
- You are able to work in a start-up environment where accuracy, accountability, quality, safety and timeliness are essentials.
- You are open-minded and have excellent interpersonal and communication skills.
- The opportunity to join an innovative biotech, a fast-growing start-up environment where teamwork, results and patients care are very important.
- A challenging and diversified position in a dynamic, young and nice environment.
- To work in a human size, respectful and professional environment.
- A fulltime permanent contract with an attractive compensation package in line with the position responsibilities and your experience.
Send your CV together with an adapted cover letter to the following address : firstname.lastname@example.org.
Your application and related information will remain strictly confidential.
Postulez à l’offre: QUALITY ASSURANCE MANAGER
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