New Product Introduction Quality Engineer - Mechelen, BE or Basel, CH
Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), France (Romainville), the Netherlands (Leiden) and in US, Boston.
We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We want to challenge the impossible. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you: The ‘make-it-happeners’.
We are looking for a New Product Introduction Quality Engineer.
Scope of the job
You will lead quality management activities for New Product Introduction (NPI).
- Provide Quality Assurance support for all aspects of New Product Introductions (NPI) including: Supplier Quality Management, Design Control, Incoming / In-process Control, Risk Management and Non-Conformances (NC) & Corrective Action/Preventive Action (CAPA).
- Focus on establishing long-term strategies for Quality, Risk Management, Inspection and Testing of Suppliers for NPI in order to sustain product competitiveness while maintaining compliance to domestic and international regulations and standards.
- Support the design and manufacture transfer process to ensure compliance with the current design controls, transfer regulations and policies. Ensure the integrity of the design control elements in design transfer including VOC translation and Control, Design Input / Output validity and completeness of DIOVV.
- Responsible for the identification of potential failure modes, risks and controls.
- Develop Quality Assurance practices for NPI projects and/or manufacturing transfer and production control. Support process monitoring to ensure ongoing product compliance.
- Support the development of material specifications and the incoming inspection process.
- Support process development, characterization and the establishment of a process window. Capture the process knowledge to facilitate subsequent validation activities and ensure the efficient and timely transfer of process knowledge and quality systems knowledge to Operations and Quality
- Select, develop and qualify the different suppliers.
- Coordinate the training of Quality Engineers and related personnel on new quality systems and equipment.
- Support the creation of production documents and quality records for new products.
- Oversight and approval of NCs and CAPAs related to new products.
- Drive a customer centric quality culture, maintain compliance to regulation and internal quality systems, and ensure that customer and regulatory requirements are incorporated into the product and process.
- Support audit preparation strategy and execution. Participate and interface with internal & external audits with regulatory representatives
- Build productive and collaborative intern/external profession relationships across design divisions & GQO functions associated with design transfer activities
- Apply lean six sigma concepts, practices and procedures of the advanced quality specialization (i.e. PDCA, DMAIC, …)
Who are you ?
Education (add qualification if relevant) & experience: Master’s degree in a scientific discipline or equivalent of education and experience.
- 5+ years of experience in manufacturing and NPI
- Experience with Quality Assurance or related functional area such as Design Transfer/Manufacturing Transfer; preferably in Pharma or another regulated industry
The Following Experiences/skill Sets Are Highly Desirable:
- ASQ-CQE, CQA or equivalent course work / experience
- ISO 13485 and ISO 14971
- Development and implementation of design and process controls (i.e. PDCA, DMAIC experience)
- Geometry Dimensioning & Tolerancing
- Six Sigma Black Belt Certification preferred
- Experience with SPC
- Familiarity with FDA/EMA Guidance on Design Controls and CAPA Methodologies, 21 CFR Part 820
- Experience with Design for Manufacturing
- Manufacturing Experience
- Human Error Prevention and/or Reduction techniques
- New Product development/R&D experience
- Familiarity with FDA/EMA guidelines on Process Validation and Control
What’s in it for you ?
You will be part of a fast growing and amazing company. As ‘make-it-happener’ you will get all the support you need to make your job successful. At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.
We are Galapagos : together we can make it happen…!