(Junior) Quality Officer
Location: BelgiumSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science 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!
THE COMPANY
Our client is a professional Biotechnology and Pharmaceutical organization, based in Oost-Vlaanderen Belgium.
The Client is a leader in the pharmaceutical industry, a global manufacturer of high-quality pharmaceuticals and specialty chemicals.
ROLE DESCRIPTION
In this role you will be responsible for quality related activities and ensuring that the clients products are compliant with all legal, market and customer requirements, and safe and effective for the end user, are released to the market.
RESPONSIBILITIES
- Manage the project portfolio of new and existing products and ensure that products comply with legal, market and customer requirements.
- Be involved and give final independent approval of technology transfer activities, risk mitigation exercises, validation studies, change management, deviation handling
- Ensure that the production process is consistent with the registered and customer requirements. This includes establishment of validation plans and evaluation of validation reports in order to grant the validated status to processes or to re-validate existing processes in case of major process changes.
- Work together with all involved departments to deliver in depth investigations in case of deviations and changes in the production process.
- Review, analyse and evaluate critical data in order to decide independently whether API, intermediates or final products comply with cGMP, customer and legal standards and ultimately decide about the final release for further processing or delivery to the customer.
- Lead external project related audits: accompany customers and authorities to make sure that they have a fair view on all process related quality documentation.
REQUIREMENTS
- You possess a Master or Engineering degree in Chemistry / Sciences
- You have knowledge of GMP legislation and guidelines
- You have gained several years of relevant professional experience in an industrial environment
- You have excellent communication skills, both in Dutch and English (spoken and written)
- You have good organization and scheduling skills.
- You know how to deal with pressure and deadlines
- You possess a good working knowledge of MS Office and Outlook.
- If you have experience with Sharepoint and/or SAP, this constitutes a plus.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Laura Hoekstra.
