The ideal candidate should already possess initial work experience in pharmaceutical production under Good Manufacturing Practices (GMP).

Who's we? 

eyetec is a young, entrepreneurial, innovative and ambitious company that is cementing its place in the pharmaceutical sector. 

eyetec is a small but growing team of curious team players who take pride in their job but also value the team dynamic. At eyetec we work independently and flexibly on a basis of trust. We also make room for fun, to increase the sense of belonging.   

What will you be doing as a Quality Assurance Officer? 

GMP stands for the legal requirements imposed on the production of medicines. As a Quality Assurance Officer, your role involves ensuring our projects comply with these standards, reporting directly to eyetec's compliance director, who also serves as a Qualified Person (QP) for various Advanced Therapy Medicinal Products (ATMP) manufacturers, including cell and gene therapies.

Your tasks will include: 

  • Assisting with GMP audits; 

  • Daily quality control support for our clients; 

  • Creating and defending visual inspection policies; 

  • Developing GMP compliance strategies; 

  • Drafting or reviewing batch records, qualification and validation documents, SOPs, and WIs; 

  • Conducting analyses on causes and risks for visual inspection, ATMP production, and cleaning or sterilization processes; 

  • Overseeing our internal quality system (ISO9001:2015); 

  • Educating and sensitizing our team on quality standards. 

Where will you be working as a Quality Assurance Officer?  

As part of the eyetec team, your work as a Quality Assurance Officer can be based in our office in Tielen, from home, or directly at client sites. As a dynamic and growing company delivering 'compliant solutions for pharma' within the regulated pharmaceutical industry, eyetec values thorough training for its employees, rewarding independence and adaptability. 

Profile 

What is expected of you? 

  • A Bachelor's degree in Pharmacy, Bioengineering, Chemistry, or Biomedical Sciences, or equivalent experience. A Master's degree is a bonus.
  • Open to candidates with different degrees who believe they are suitable. Please explain why in your application.
  • Experience with QA in a GMP environment, familiarity with ATMP production and knowledge in washing/sterilization or visual inspection of parenteral drugs are advantageous.
  • Strong communication skills in Dutch and English are essential. French, Spanish, Italian or German is beneficial.
  • Ability to negotiate solutions within a team, prioritizing compliance while mindful of technical and financial constraints.
  • Analytical skills to identify the root causes of deviations.
  • Comfortable working in a GMP regulated environment, adhering to pharmaceutical client's procedures.
  • Ambition to grow within an expanding company and deepen your knowledge of drug production.

Job-Related Competencies

  • Educate and train staff on quality principles.
  • Evaluate the cost of non-conformities.
  • Create and implement measurement and analysis protocols for hygiene, safety, environment and quality.
  • Establish reference systems for hygiene, safety, environment and quality.
  • Test and evaluate the quality of products or services: specifically pharmaceutical products.
  • Encourage staff awareness of organization, quality, and safety standards.
  • Provide technical support for quality, maintenance, and methods.
  • Implementing actions: Organizing pharmacovigilance 
  • Monitor quality and enforce corrective measures to ensure regulatory compliance and customer satisfaction.
  • Develop and apply methods for quality monitoring awareness.
  • Analyze non-conformity cases and determine corrective actions.
  • Identify issues such as incidents and quality problems.
  • Recommend and implement preventive and corrective measures.
  • Work within global and specific quality management systems.
  • Perform quality, supplier and environmental audits.
  • Manage and update documentation.
  • Analyze quality data to identify trends and areas for improvement.
  • Verify the qualifications of resources and compliance of instruments.
  • Refine and ensure the application of quality procedures.
  • Oversee the work of suppliers or service providers.
  • Validate measurement and analysis results.
  • Share outcomes with quality, production teams, customers, and representatives.
  • Oversee quality controls on products throughout production and packaging.
  • Drive continuous improvement in quality assurance.
  • Suggest and implement changes to enhance productivity, quality, and safety.

Personal Competencies

  • A strong capacity for learning and absorbing new information quickly.
  • Inventiveness and creativity in solving problems.
  • Flexibility to adapt swiftly to new situations or changes.
  • A keen eye for detail, ensuring precision in all tasks.
  • The capability to work autonomously, managing tasks and projects independently.

Offer  

What is offered to you? 

  • Intensive training in a fascinating and complex market with many career opportunities. 

  • Essential tools for your role, including a personal laptop and mobile phone.
  • The chance to grow within an energetic and burgeoning company.
  • A stimulating full-time position, competitive salary and additional legal benefits, tailored to your experience.
  • Mentorship from an experienced Qualified Person (QP).

  • Our main office is in Tielen, offering the flexibility of remote work and the opportunity for client visits.
     

Place of employment

  • Kemelbeekstraat 80D, 2460 Tielen

Required Qualifications

  • A Master's degree in Drug Development: Biopharmaceutical Sciences, Industrial Sciences: Biochemistry, Biology, or a similar qualification gained through professional experience.
  • A minimum of 2 years' work experience.

Language Proficiency

  • Excellent command of Dutch and English; proficiency in French is advantageous.

Other Requirements

  • A valid driving license (Category B).

Contract Details

  • Permanent position with an indefinite contract.
  • Full-time employment with daytime hours.

Application Process

  • Interested candidates should apply by submitting a CV along with a cover letter.
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