SIRE® 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!
The companyOur client is a professional Pharmaceutical organisation, based in Noord-Holland Netherlands. This is your chance to work at an international company!
Role descriptionYou are accountable for day to day testing activities in according with cGMP guidelines, GMP as well as EHS SOP’s.
ResponsibilitiesSupport the value stream organizational structure, take care of all non-routine Quality Control activities for example:
- Laboratory Quality Control Product Specialist (Knowledge of specific product characteristics)
- Lead of phase II OOS- en complex investigations
- Stability trending,
- Lab Outsourcing,
- Quality Analyst Job Training
- Equipment care (maintenance/validation/calibration)
- SME during Regulatory and client inspections
• Quality Control testing
- Back-up for testing and evaluation of quality of Raw materials, API, Packaging components (primary and printed) Drug Product throughout manufacturing process and during shelf life of the drug product (Stability testing)
- Back-up for testing, approve or reject of the raw materials, packaging materials & finished products, stability samples as per the committed time lines.
Requirements- Experience with pharmaceutical processes, chemical analysis techniques, and cGXP
- Experience on instrument like HPLC, GC, KF.
- Familiar with process automation.
- Familiar with Lean Lab concept.
- Experience & exposure to work in regulatory environment as well as Regulatory Audit like EU cGMP inspection, US-FDA, ANVISA
- Good Knowledge of English (verbal and in writing)