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Sr QC Officer / Stability Coordinator
HAL Allergy in Leiden is searching for a Sr QC Officer / Stability Coordinator for our QC Department.
In this position you are responsible for the set up and maintenance of stability studies and supporting the department in other QC processes. You make sure all products of HAL Allergy comply with registration regulations and ensure compliance of the studies to the relevant quality procedures and regulations.
Tasks and Responsibilities
  • Coordinate of all aspects of GMP stability studies of our products.
  • Initiate and reports stability studies with regard to changes and registration aspects, with compliance of the regulations.
  • Lead the stability meeting with the RA, Development, QC and QA departments.
  • Initiate and coordinate expanding durability of our products, on the base of the results of the stability studies.
  • Responsible for the quality and regulatory compliance of all QC procedures.
  • Prepare stability trend overviews and write stability reports to verify product shelf life and product expiration dates.
  • Initiate and write deviation reports, change control and CAPAs.
  • Conduct continuous improvement projects related to quality and cost improvements.
  • Be active in Lean thinking, actively participate in a culture of continuous improvement, bring in new innovative ideas, out of the box, and sustain its impact across the laboratory.
  • Recognize waste and propose plans to- and be active in elimination.
  • Actively pursue limitation of variation in execution of standardized laboratory activities such as but not limited to release and stability testing.
  • SME during Regulatory and client inspections.
Requirements
  • WO (biochemistry, molecular biology, biotechnology or similar) or HBO with additional experience.
  • Preferably with >5 years of working experience in a similar position within a cGMP (bio)pharmaceutical company.
  • Knowledge of English language, oral and written.
  • Knowledge of MS-Office and relevant quality software, Q-Pulse (pre) and LIMS.
Personal & Professional Skills
  • Strong knowledge of cGMP in relation to Quality Control.
  • Strong coordination skills and a pro-active attitude.
  • Able to convince by natural networking skills and strong presentation methods.
  • Thorough: ability to carry out tasks with an eye for completeness (e.g. studies achieved according to procedures /protocols).
  • Self-organised: ability to focus and to plan accordingly and independently.
  • Detail-oriented: analytical mind set, ability to pick up on important details.
  • Problem solving: ability to identify problems (out of trend results, trends with equipment, or test results), discuss these within the team, and to find a solution.
  • Co-operative: ability to work within a team and with other teams to drive projects forward according to agreed time lines.
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.