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Validation Lead - Qualification and Validation
Leiden (NL) | 40 hrs.
An exciting Validation Lead position is now available in our close knit Validation Team!
In the role of Validation Lead - Qualification and Validation, you will play a vital part in ensuring compliance with regulatory standards and industry practices throughout the qualification and validation processes. Working closely with different teams within the company, you will maintain high-quality and dependable manufacturing operations.
In this challenging position, you can create an impact on our validation strategy in a culture that is characterized by an entrepreneurial spirit. If you look forward to playing a role in helping people live happier and healthier lives, apply below and we look forward to meeting you!
Your tasks
- Develop and execute qualification and validation strategies following regulatory guidelines, which include IQ/OQ/PQ protocols and reports.
- Work closely with engineering, manufacturing, and quality teams to uphold compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDocP).
- Create validation master plans, protocols, reports, and standard operating procedures (SOPs) to ensure precision and thoroughness.
- Perform risk assessments and offer advice on minimizing risks associated with qualification and validation tasks.
- Investigate deviations and non-conformances, and implement corrective and preventive actions (CAPAs) to tackle underlying issues.
- Stay informed about industry trends, regulations, and best practices in qualification and validation, and share knowledge within the organization.
- Engage in both internal and external audits and inspections.
- Maintain oversight of the VMP, monitor adherence trends, and ensure compliance with guidelines.
You have
- HBO or Bachelor's degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or a related field.
- Demonstrated track record as a validation specialist, particularly in qualification and validation within the pharmaceutical sector.
- Profound comprehension of GMP regulations and industry standards.
- Knowledge of qualification and validation procedures for equipment, facilities, utilities, computer systems, manufacturing processes, and analytical methods.
- Proficient in quality systems, documentation practices, and risk assessment methods.
- Skilled in deviation and CAPA management, root cause analysis, and change control processes.
- Meticulous attention to detail, analytical reasoning, and problem-solving abilities.
- Strong communication and interpersonal skills for effective collaboration with diverse teams.
- Good command of the Dutch and English language, both verbally and in writing.
Who are we looking for?
You are a validation expert who wants to play an active role in developing and improving validation procedures at HAL Allergy. With a self-starting attitude, you possess a keen eye for detail and an analytical mindset.
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.
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