QA Officer Deviation Specialist at HAL Allergy
Improvement of Quality Management Systems and assurance of GMP compliance with special emphasis on the reduction of deviations, minimisation of recurrent issues by proper root cause analysis and increase of GMP awareness in the functional groups.
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.
- Chair regular Deviation Board meetings to assess criticality of deviations, and identify CAPAs.
- Investigation and resolution of deviations to allow batch release.
- Assess root-cause investigation for major and critical deviations to prevent re-occurences.
- Timely escalation.
- Review and approve deviation and CAPA records, ensuring timely closure.
- Increase GMP awareness in the functional groups, i.e. Production and QC, via training and good practices.
- Develop Quality Metrics and provide data of Quality Systems (Deviations, CAPA’s) for presentation in Management Review.
- Preparation of Product Quality Reviews.
- To participate in in- and external (supplier) GMP/GDP audits; Audit preparation, execution and follow-up as qualified auditor.
- Prepare Audit reports including corrective and preventive action plans (CAPA’s) and follow-up the CAPA until completion.
- Support of regulatory (IGZ) inspections and of clients’ audits; Member of internal audit team.
- Leading quality based projects working as part of a multidisciplinary team.
- Input in tier-2 processing for debottlenecking of quality issues.
- HBO- Academic degree (Life Sciences, Biopharmaceutical Sciences, Pharmacy).
- Working experience in the pharmaceutical industry (HBO > 5 yrs, Ac > 2 yrs).
- Working knowledge of GMP guidelines.
- Excellent knowledge and command of both Dutch and English, in speaking, reading and writing.
Personal and professional skills:
- Accuracy and quality awareness.
- Excellent communication skills (both verbally and in writing).
- Persuasive, able to convince others.
- Pro-active and sense of urgency.
- Flexible and team player.
- No 9-5 mentality.
- Stress resistant.
No unsolicited assistance from search firms is accepted for this employment opportunity