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.

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.

 Qualifications

  • 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’ experience in compliance projects, validation and/or qualifications in the pharmaceutical  industry.

  • Sound 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 situation.

  • Sense of urgency, able to set priorities.

  • Excellent knowledge of the English and Dutch language (verbally and written).

  • Customer-focus. 

  • Team player with hands-on mentality.

  • Excellent technical writing skills.

  • Provides direction, as appropriate, to other members of the project team.

  • Must have excellent analytical skills and attention to detail.  

     

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