QA Specialist (Training)
Leiden (NL) | 36 - 40 hrs.
We are looking for a QA Specialist (Training) with a passion for training and compliance. Your primary focus will be on developing and designing effective training programs, conducting engaging sessions, staying updated on industry trends, maintaining thorough training documentation, and tracking training effectiveness. Additionally, you will ensure GMP compliance in handling Quality Records, including Deviations, CAPAs, and Change Controls. This role combines technical expertise, attention to detail, and the ability to empower others through knowledge-sharing and continuous improvement.
Your tasks
• Maintain & improve the Quality Systems within HAL Allergy with the biggest focus on Training Management:
o Develop and Design Training Programs
o Conduct Training Sessions
o Stay Up to Date with Industry Trends
o Maintain Training Documentation
o Track Training Effectiveness
• Ensure GMP compliance with the handling of Quality Records (e.g., Deviation, CAPA & Change Controls)
• Develop and review standard operating procedures (SOPs) related to quality systems.
• Assess & authorize (major) quality related Change Controls.
• Participation or leading Continuous Improvement programs within the company.
• Work closely with QA Product Release to lead investigations related to complex deviations.
• Executing & reporting of internal and supplier audits in the position of lead auditor.
You have
- A Bachelor degree (Life Sciences, Biopharmaceutical Sciences, Pharmacy).
- Relevant work experience within the pharmaceutical industry.
- Experience with designing and delivering training programs.
- Preferably experience with the implementation/use of an electronic Learning Management System and/or Training Management System.
- Preferably experience with quality systems, including deviations, CAPA and change management processes.
- Familiar with Root Cause Analysis tools, e.g. Fishbone, 5 'whys'
- Project experience.
- Experience with both audits and inspections.
- Good knowledge of GMP guidelines.
- Good command of the Dutch and English language, both spoken and written.
Who are we looking for?
You are a dedicated QA professional driven by a commitment to excellence and continuous growth. Sharing knowledge and motivating others energizes you. With strong analytical and communication skills, you simplify complex processes and work effectively with teams to achieve goals. Solution-oriented and detail-focused, you balance strategy with practical execution, making a positive impact on quality and improvement.
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 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.
- You will be working in our dynamic headquarters in Leiden, where we work on the full project 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 European top 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 Hall 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 a part of an innovative and challenging pharmaceutical manufacturer, then this is your 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.
