Senior QA Associate
Location: NetherlandsSIRE 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 Pharmaceutical organization, based in Noord-Brabant Netherlands.
Driven by the commitment to patients, the client brings innovative products, services and solutions to people throughout the world.
ROLE DESCRIPTION
• Act as a first point of contact in case of production queries (quality related) during packaging and labeling operations. Work together with production and maintenance team to resolve the quality related problems.
• Review and approve class I Non Conformances
• Review and approve batch record exception reports
• Coach production and maintenance staff to improve on quality and to limit number of errors
• Perform finished product checks during (commercial) production runs
• Complete batch release preparation prior to Qualified person disposition.
RESPONSIBILITIES
- Set up department goals
- Compilation of weekly/ monthly/ annual reports
- training management
- Assignment of responsibilities among team members
- Compliance of GMP and QEHS
- Point of contact for Change Control for internal/ external stake holders
- Execution of Risk Assessmentrs with the purpose of improving the QMS
- Initiate and manage the completion of optimization QMS projects
- Perform Change Control tasks in all disciplines (process, engineering, lab and automation)
REQUIREMENTS
• Bachelor’s degree in Life Sciences or related field or the equivalent combination of education and/or experience.
• Typically 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review and investigations.
• Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/ or Good Clinical Practice (GCP) knowledge with the ability to interpret and apply in mainly routine cases.
• Manufacturing and/or Quality analytical processes and operations.
• Fluent in English language
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.
