QA Officer Senior
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-Brabant Netherlands.
• 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.
• 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)
• 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.
The Company
The client wants to serve patients. They develop and produce medicines and therapies that restore health or save lives.Role Description
You will act as a first point of contact in case of production queries (quality related) during packaging and labeling operations.You will 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.
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