Pharmaceutical Validation Specialist at HAL Allergy
Maintaining a compliant validation process for GMP-regulated systems and that validation and qualification is performed in compliance with cGMP guidelines (Annex 15 Eudralex; ICH Q2 guidelines).
- Execute, maintain and optimise the validation strategy (Validation Master Plan) in cooperation with the technical departments;
- Keep abreast of changing regulatory requirements and guidelines and oversee validation testing in the field. Ensure the implementation into operations of relevant guidelines;
- Review and approve (re)validation protocols and reports regarding Utilities, Equipment, ICT, Processes and Quality Control laboratory testing;
- Analyze and review validation data, report, audit and develop validation protocols (IQ/OQ/PQ, including media fills);
- Review, determine impact of, and approve validation deviations and advise validation/ qualification study project leads; inform the Qualified Person in case of critical validation deviations;
- Liaise with technical departments (Technical Services, ICT, QC and Production) to ensure regulatory compliance regarding validations. This entails training of staff and the execution of the planned activities without line management responsibility;
- Team member of the inspection team for external inspections and customer audits. Lead auditor for internal inspections;
- Take part in projects as Quality Assurance lead and initiate continuous quality improvements;
- Executing tasks for Quality Management Systems;
- Improvement of processes and procedures;
- Leading quality investigations when various department may be involved;
- Advocating quality policies and translating GMP-guidelines to internal policies and procedures.
- Bachelor’s degree, e.g. in engineering or science with 7+ years of experience;
- Laboratory Quality Assurance and/or process technology background;
- Sound knowledge of GMP regulations. Experience with FDA processes is a plus;
- Demonstrated commitment to quality.
Personal & Professional Skills:
- Ability to carry out several activities and projects in parallel.
- Pro-active, independent and goal-oriented.
- Sense of urgency, able to set priorities.
- Ability to work under time pressure.
- All round team player with hands-on mentality.
- Excellent social and communication skills.
- Excellent people management skills and ability to motivate staff and promote team building.
- Excellent technical writing skills.
- Knowledge of Microsoft Office
- Excellent knowledge of Dutch and English, both verbal and written
HAL Allergy is a modern company with high quality pharmaceutical GMP manufacturing and research facilities located in the Leiden Bio Science Park. With offices in seven European countries, we are one of the top European players in the field of allergy diagnostic and treatment. Since 1959 we have gained experience in developing, producing and selling allergy therapies for the treatment and prevention of allergic diseases.
These immunotherapies are used primarily against common allergies such as hay fever, house dust mite allergy and allergic reactions towards wasp or bee stings. Beside the development and production of allergy vaccines, HAL Allergy started a new business in 2012. This new Contract Manufacturing Organization (CMO), named HALIX, is engaged in the production of biotechnological products for preclinical and clinical studies.
HAL Allergy Group is a mid sized company with headquarters in Leiden. We employ around 300 highly specialized people acorss various functions. The departments at our headquarters include development, production, quality assurance and control, clinical and registration. Our staff work closely together with leading research institutes. At our locations in Germany, Poland, Austria, Spain and Italy we mainly focus on service and sales activities.