Quality Assurance Officer
Location: NetherlandsSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Limburg Netherlands.
- Monitoring compliance with all applicable GMP and safety standards.
- Supporting the Qualified Person in his role, including audits and quality training.
- Writing, reviewing and approving documentation (SOP’s, manufacturing and quality instructions, validation of protocols and reports, non-conformities, change requests).
- Handle, distribute and archive controlled documents.
- Preparing data for trending (QRB, Annual Product Review) and support internal and external audits.
- Knowledge of GMP is an advantage.
- Good communication skills in English.
- Accuracy, tidiness, self-organized, flexible, attention to detail, team player.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.
The Company
They encourage their employees to challenge themselves and are constantly looking for new opportunities that will foster creativity and success.Role Description
The QA Officer is responsible for the planning and execution of daily quality assurance activities while ensuring compliance with international quality requirements as defined by the applicable guidelines (e.g. FDA, EMA, ICH) and all existing GMP standards in the area of responsibility.Responsibilities
- Planning and executing quality assurance activities (document management, batch records and label issuance, batch record review, equipment and supplier qualifications etc.) including documentation.- Monitoring compliance with all applicable GMP and safety standards.
- Supporting the Qualified Person in his role, including audits and quality training.
- Writing, reviewing and approving documentation (SOP’s, manufacturing and quality instructions, validation of protocols and reports, non-conformities, change requests).
- Handle, distribute and archive controlled documents.
- Preparing data for trending (QRB, Annual Product Review) and support internal and external audits.
Requirements
- Intermediate vocational education or BSc in chemistry/biotechnology.- Knowledge of GMP is an advantage.
- Good communication skills in English.
- Accuracy, tidiness, self-organized, flexible, attention to detail, team player.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.
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