(Sr) QA Officer at HAL Allergy
As QA Officer you maintain & improve the Quality Systems with Hal Allergy Group and ensure GMP compliance with the handling of Quality Records (e.g. Deviation, CAPA & Change Controls).
Tasks and responsibilities
- You actively participate in and contribute to our ongoing Continuous Improvement initiatives for working methods, procedures and quality systems to comply with the current FDA/EU standards.
- You lead research into quality problems where multiple departments are involved.
- You assess and authorise quality related Change Controls and are able to lead investigations related to deviations.
- You draft /update new procedures for the QA department to ensure alignment with regulatory expectations and advise others within the organisation if needed.
- You participate in regulatory inspections (e.g. back office lead, screener).
- You promote the quality policy within the company and projects and translate GMP-guidelines to internal standards and procedures.
- Bachelor degree and at least 3-5 years of work experience within QA in the Pharmaceutical Industry.
- You have experience with Quality Systems including deviations, CAPA and Change control processes.
- Good knowledge of GMP guidelines.
- Good command of both the Dutch and English language, both verbally and in writing.
Personal & Professional Skills
Are are a result oriented professional that takes accountability for own tasks and actions. You seek cooperation with other colleagues and departments within the organisation. You are able to adapt to a dynamic environment.