HAL Allergy vacancy search engine

General information

QA Officer Validation
As a QA Officer Validation (Product Release/Systems) you work in the QA Product Release team and the QA Systems team. The PR team is primarily responsible for reviewing completed product and packaging batch records and ensuring GxP compliance across the organization. In this position you are also responsible for the validation part within the Systems team for maintaining a compliant validation process for GMP regulated systems.
Tasks and Responsibilities
  • Execute, maintain and optimise the validation strategy (Validation Master Plan) in cooperation with the technical departments.
  • Keep abreast of changing regulatory requirements and guidelines and oversee validation testing in the field. Ensure the implementation into operations of relevant guidelines.
  • Review and approve (re)validation protocols and reports regarding Utilities, Equipment,  ICT,  Processes and Quality Control laboratory testing.
  • Analyze and review validation data, report, audit and develop validation protocols (IQ/OQ/PQ, including media fills).
  • Review, determine impact of,  and approve validation deviations and advise validation/ qualification study project leads; inform the Qualified Person in case of critical validation deviations.
  • Liaise with technical departments (Technical Services,  ICT, QC and Production)  to ensure regulatory compliance regarding validations. This entails training of staff and the execution of the planned activities without line management responsibility;.
  • Team member of the inspection team for external inspections and customer audits. Lead auditor for internal inspections.
  • Take part in projects as Quality Assurance lead and initiate continuous quality improvements.
  • Executing tasks  for Quality Management Systems.
  • Improvement of processes and procedures.
  • Leading quality investigations when various department may be involved.
  • Advocating quality policies and translating GMP-guidelines to internal policies and procedures.
Requirements
  • A minimum of 7 years of relevant work experience.
  • Laboratory Quality Assurance and/or process technology background.
  • Sound knowledge of GMP regulations. Experience with FDA processes is a plus.
  • Good command of the Dutch and English language, both verbally and in writing.
  • Excellent technical writing skills.
  • Knowledge of Microsoft Office
Personal & Professional Skills
  • Professional Self Development
  • Result oriented
  • Accountability
  • Cooperation
  • Adaptability
  • Analytical thinking
  • Tech savvy
  • Persuasive
Offer
  • We offer you a highly dynamic job in an interesting environment.
  • You will be working from our headquarters in Leiden, where the products are produced on site.
  • HAL Allergy offers great benefits including a competitive salary, 13th month, 30 holidays, contribution to pension and health insurance.
Applications and more information
Interested? We look forward to receiving your application. To apply, please click the "Apply" button below to the right where you will be prompted to upload your CV first. 
Company Information

HAL Allergy is a modern leader in the field of biopharmaceuticals, located in the Leiden Bio Science Park in The Netherlands. Our core business is the development and manufacturing of therapies and diagnostics for allergic diseases.

 

With offices in major European countries, HAL Allergy is one of the European top players in the allergy immunotherapy business. Established in 1959 HAL Allergy has a long experience in developing, producing and selling allergy therapies with an immuno-modulatory effect, resulting in a reduction of symptoms and long-term disease suppression. These therapies are primarily used against common allergies such as hay fever, house dust mites allergy and allergic reactions towards wasp or bee stings.

 

We employ around 300 highly specialized people across various functions. The departments at our headquarters include Research & Development, Production, Quality Assurance, Clinical Development and Regulatory Affairs. Our staff works closely together with leading research institutes. At our locations in Germany, Poland, Austria, Spain and Italy we mainly focus on service and sales activities.

 

We are a steadily growing and dynamic company with a culture that is characterized by entrepreneurial spirit and a friendly and helpful atmosphere. The patient’s well-being is always our top priority. This combination is the basis for an interesting and challenging environment.

 

In addition to the core business of HAL Allergy, our subsidiary HALIX was founded in 2012. HALIX is a contract development and manufacturing organization (CDMO) licensed for the contract manufacturing of clinical and commercial medicines according to GMP standards. As an end‑to‑end service provider, HALIX will serve its customers the full range from the first development steps to start of commercial production after successful registration of products.