General information
Qualified Person
The QP within HAL Allergy is legally responsible for certifying batches of medicinal products before they are used in clinical trials or available on the market. But our new QP doesn't just need expertise in manufacturing practice. You also need to understand the factors that can affect the safety of medicines and supply chains.
Due to growth of the company, HAL Allergy is looking for a Qualified Person (QP) who takes responsibility for the release of our (investigational) Medicinal Products. You play a critical role in ensuring that no product is released for supply or sale without certification.
Your tasks
- Batch certification and release of (investigational) medicinal products in accordance with the Marketing Authorisation/IMPD and in accordance with current EU-Directives (specifically Article1 from Directive 23001/83/EC and Directive 2003/94/EC).
- Investigate in close collaboration with the Deviations Specialist and approve/finalize the deviation(s).
- Approval of Change Controls.
- Focal point of contact with regulatory authorities (IGZ, Farmatec, PEI) to maintain the compliance status of HAL.
- Participation in R&D Project teams as QA-representative.
- Approval and execution, including follow-up of internal – and external (supplier) audits.
- To support quality-based decision processes.
- Focal Point of Contact for external audits.
Furthermore:
- To develop and train QA-Officers and actively support a climate for continuous improvement
- Maintenance of the Quality Management Systems: Auditing, Deviations and Product Quality Review.
- Investigation of Product Quality Complaints.
- Installation and maintenance of Quality Agreements with suppliers and subcontractors as part of supplier qualification program.
You have
- Academic degree (preferably as a pharmacist).
- Eligible as a Qualified Person by IGZ.
- Experience (QP: 2yrs +) with aseptical manufacturing.
- Solid knowledge of (bio-)pharmaceutical processes and – industry (R&D, QC and production).
- Experience with the implementation and maintenance of Quality Management Systems.
- Audit experience and interview techniques.
- Fluent in the Dutch and English language.
Who are we looking for?
You are a self starter able to think critically and ready to take charge in high stakes situations. You can make hard choices based on your interpersonal and problem solving skills. You are naturally curious and open to learn. We expect a proactive attitude and a continuous search for opportunities to improve processes and product quality.
Our offer
- You will be part of a steadily growing and dynamic biopharmaceutical company offering a great environment for self-starters.
- A culture that is characterized by entrepreneurial spirit and close and transparent communication. The patient’s well-being is always our top priority. This combination is the basis for an interesting and challenging environment.
- You will be working in our dynamic headquarters in Leiden where we work on the full product pipeline from development to commercial production.
- Being part of a company that is geared towards helping people live happier and healthier lives.
- A competitive salary that matches your responsibilities and experience.
- A 13th month salary.
- 30 leave days
- Company contribution to a pension package and health insurance.
Your application
We look forward to hearing from you! We are interested in your CV, but we also want to find out more about your ambitions, your personality and what drives you to apply. So be sure to include a brief cover letter telling us why you are a match for this position. The application process consists of an introduction by the Recruiter, two interviews either via video call or live at our office in Leiden with the Hiring Manager and/or a Department Specialist followed by contract negotiations. Depending on the vacancy, an assessment could be part of the process.
Important notice to search firms and recruitment agencies
HAL Allergy does not accept unsolicited approaches from recruitment agencies and/or search firms (such as, for instance, the sending of resumes) for any job posted on this or a referring website. All recruitment agencies and search firms are required to contact HAL Allergy Recruitment via recruitment@hal-allergy.com to enquire about a potential recruitment or search agreement with HAL Allergy.
HAL Allergy, for those who seek pharmaceutical innovation
HAL Allergy is one of the top European players in the development, production and distribution of allergen immunotherapies for the treatment and prevention of allergic diseases. We focus on the development and manufacturing of modified allergen extracts for the therapeutic and diagnostic purposes of respiratory and food allergies. With all our activities the patient's well-being is always top of mind. At HAL Allergy, we foster open discussions, an entrepreneurial spirit and close collaborations within the teams and with our international colleagues summing up to more than 300 highly specialized people across various positions. If you too would like to become part of an innovative and challenging pharmaceutical manufacturer, then this is a perfect opportunity!
HAL Allergy is headquartered in Leiden, where all disciplines work under one roof, from development to sales. We work in an informal, culturally diverse organization with room for growth and continued personal development. HAL Allergy is located in the middle of the thriving and energetic Leiden Bio Science Park, the largest innovation district of the Netherlands in the field of Life Sciences & Health. The central train station and the ancient city center of Leiden are just a 5 minute bike ride away from our office.
