QA Officer HALIX at HAL Allergy
The QA Officer will be responsible to build, maintain and expand the Quality Management Systems at HALIX for projects, related to cell culture, fermentation, down-stream processing and aseptical filling of biological and immunological products.
Tasks and responsibilities
- Implementing GMP/FDA-guidelines into internal quality policies and procedures for continuous improvement of HALIX’ Quality Management Systems.
- Leading project-related deviations and root-cause investigations.
- Prepare disposition of the deviation for the Qualified Person.
- Initiating change controls, including implementation plan and timely closure.
- Preparing, evaluating and following-up on monthly Management Review.
- QA-lead for HALIX Project teams.
- QA-representative to the customer (Contract Giver) on a daily basis.
- Batch record and related raw data review; preparation of release package for disposition by the Qualified Person.
- Writing and approving procedures and work instructions.
- Training of the project team in compliant execution of the project.
- Approval of the validation strategy (Validation Master Plan). Review and approval of validation protocols and reports regarding equipment, processes and products.
- Bachelor’s degree in life sciences (Biotechnology or related) or comparable level through experience.
- Minimum of 5 years’ working experience with cell culture operations in GMP/FDA environment.
- At least 2 years’ relevant experience in compliance projects, validation and/or qualifications in the pharmaceutical industry.
- Solid knowledge of GMP/FDA regulations.
- Experience with quality management systems (deviations, quality investigations, change controls).
Personal & Professional Skills
- Pro-active, independent and goal-oriented; quickly adaptable to new situations.
- Sense of urgency, able to set priorities.
- Excellent knowledge of the English and Dutch language (both verbally and written).
- Team player with hands-on mind set.
- Excellent technical writing skills.
- Provides direction, as appropriate, to other members of the project team.
- Must have excellent analytical skills and attention to detail.
Founded in 2012 as a corporate venture and spin-off of HAL Allergy, HALIX is a contract development and manufacturing organization (CDMO), based in Leiden, the Netherlands. The company is licensed for the contract manufacturing of clinical and commercial medicines according to GMP standards. HALIX leverages advanced biopharmaceutical technologies and provides the full portfolio of pharmaceutical documentation of GMP production processes, as well as production of units which are required for clinical approval. HALIX, as an end-to-end service provider, will serve its customers the full range from the first development steps to start of commercial production after successful registration of products. More information is available on: www.halix.nl.