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General information

Head of QA
The Hal Allergy QA department plays a central and crucial role in the continuity of the supply chain, manufacturing of immunotherapy products and new product launches. As an experienced leader with a commercial mind-set, you will be responsible for overseeing and managing all QA related activities whilst being fully aware of the operational delivery requirements (e.g. supply chain and manufacturing). By using a pro-active mentality and hands-on approach, you will manage and coach the QA teams on the processes of batch review, quality records handling, production support(PIP), Product Quality Reviews, etc.

Meanwhile you will review and coordinate the troubleshooting around deviations, trend analyses and root cause analyses. This will yield a proper development, maintenance and continuous improvement of processes at the quality department, all according to the current and existing GMP regulations. Finally, implementation of improved processes requires a clear level of communication and (un)solicited advice to the relevant stakeholders.
Tasks and Responsibilities

In this role, you are responsible for creating and maintaining a policy of continuous quality improvement within the company to support quality based decisions processes and keep quality systems in a state of compliance.
This includes the process of batch review of both HAL Allergy products and contracted CMO batches. Developing partnership with Production, Tech Services, QC, RA, QP’s and Tech Transfer to ensure timely completion of batch documentation and other deliverables.

 

  • Managing the QA Quality Systems and QA Product Release departments, coordinate daily activities, set priorities and ensure effective daily operation of the departments
  • Ensure timely delivery of batch documentation to the QP’s and with that timely release of batches
  • Implement and maintain programs and processes to ensure high quality pharmaceutical products and continued compliance with (c)GMP
  • Participate and manage Regulatory Inspections (e.g. IGJ, FDA) and client audits when required
  • Participate in Continuous Improvement programs, e.g. lean methodology, RCA improvements
  • Maintaining internal & external audit programs
  • Maintaining Vendor qualification
  • Serve as a lead of investigations and corrective and preventive action (CAPA) recommendations related to product manufacturing/testing when required
  • Keep track of developments in the areas of validation, document management and quality systems and translate these to possible challenges for the organisation
  • Translate and implement the strategic plan to specific Quality metrics and KPI’s
  • Establish and maintain appropriate QA oversight of validation of equipment & computerised systems
  • Maintenance and oversight of the Batch Review process, Quality issues and Product Quality Complaints
  • Develop and advocate a quality culture and vision on improvement processes within HAL Allergy
Requirements
  • Master degree in Science or a related field
  • A minimum of 6 years of relevant work experience in the pharmaceutical industry, in a QA or RA role, including Product Release, Quality Systems and Validation.
  • Broad experience with quality related issues in aseptic production
  • Good command of the Dutch and English language, both verbally and in writing
  • Audit experience and interview techniques
  • Experience with FDA inspections would be beneficial
Personal & Professional Skills
  • Result oriented
  • Accountable
  • Efficient
  • Adaptable
  • Strong at Planning & Organizing
  • Analytical thinking
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.