Senior Associate QA
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 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.
- Preferably 0.5 year 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.
- Early: 0630-1500 every other week
- Late: 1430-2300 every other week
- Night: 2230-0700 for now every 8 weeks (not first 3 months)
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Windimi Post.
The Company
Our customer is one of the largest supplier of medicines in the Netherlands. This is a unique opportunity to work in one of the largest pharmaceutical companies in the world!Role Description
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.Responsibilities
- 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.
Requirements
- EU Pharmacist degree (or equivalent) is required (e.g. BIG registered)- Preferably 0.5 year 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.
Other information
This job is 5 working days (mon-fri), in 3 shift operation- Early: 0630-1500 every other week
- Late: 1430-2300 every other week
- Night: 2230-0700 for now every 8 weeks (not first 3 months)
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Windimi Post.
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