Senior QA 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 Noord-Holland Netherlands.
- Responsible for reviewing master documents and batch documentation.
- Responsible for performing internal and external audits autonomously.
- Perform batch and (QC) test record review, including approval.
- Write, review and approve applicable controlled documentation, eg. batch records, (audit) reports, protocols and other cGxP
QMS documentation
- Performing initiation, review and assessment of deviations, change control requests, CAPA’s, OOS and other QMS input.
- Back up for QA Manager.
- Minimal 6 years of experience in a similar role in an international working environment and minimal 8 years of experience in
pharmaceutical industry.
- Minimal 2 years of experience in auditing pharmaceutical and laboratory organisations.
- Experience in GMP production/ Quality Control.
- Excellent understanding and knowledge of cGMP/ ICH guidelines for both EU and USA.
- Understanding of state-of-the-art practice in the cell therapy field.
- Experience with competent authority inspections
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 are a biopharmaceutical company that focuses on the treatment of blood cancers and inherited blood disorders.Role Description
A challenging position in an innovative, fast growing, biotechnology company. Working in a fast-paced dynamic environment brings the opportunity to make your own mark within the organization.Responsibilities
- Responsible for correct use of QA systems, SOP’s and Procedures.- Responsible for reviewing master documents and batch documentation.
- Responsible for performing internal and external audits autonomously.
- Perform batch and (QC) test record review, including approval.
- Write, review and approve applicable controlled documentation, eg. batch records, (audit) reports, protocols and other cGxP
QMS documentation
- Performing initiation, review and assessment of deviations, change control requests, CAPA’s, OOS and other QMS input.
- Back up for QA Manager.
Requirements
- B.Sc./ M.Sc. in Biotechnology, Chemistry or equivalent field.- Minimal 6 years of experience in a similar role in an international working environment and minimal 8 years of experience in
pharmaceutical industry.
- Minimal 2 years of experience in auditing pharmaceutical and laboratory organisations.
- Experience in GMP production/ Quality Control.
- Excellent understanding and knowledge of cGMP/ ICH guidelines for both EU and USA.
- Understanding of state-of-the-art practice in the cell therapy field.
- Experience with competent authority inspections
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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