Quality Control Technician
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.
- 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
- Handling failure investigations.
o Timely management of (OOS) investigations, CAPAs, Regulatory commitment, GRAs, Audits, Global Standard implementation to ensure sustainable compliance.
o Write study protocol and report as part of failure investigations.
o Actively participate in advanced problem solving, root cause analysis, troubleshooting, interpretation/consultation, verification of quality and test results discussions.
o Effectuate agreed arrangements on deviations and reporting on progress.
o Support Complaints investigation by developing test methods and performing the test accordingly.
- Documentation
o Assistance in the establishment of standards, specifications, sampling plans, test procedures, or any other laboratory control mechanism.
o Assistance in the development and implementation of the quality control programs to ensure reliability of testing procedures, proper function of laboratory equipment and compliance with regulations; prepare and maintain applicable records.
o Handling in the preparation, review and finalization of specifications, standard test procedures and standard operating procedures.
o Participate in the development of new laboratory procedures and techniques; plan, develop and present workshops.
• Outsourcing
o Assistance in selection, audit & approval of contract laboratories.
o Managing outsourced QC laboratory activities (review, shipment, planning, progress, timely delivery).
• Qualification
o Maintain own technical expertise, personal skills and interpersonal skills needed to perform their duties in line with Site expectations.
o Demonstrate decision-making abilities in all aspects of performance.
o Trains and/or supervises training of other lab staff.
o Coordinate employees rotations to include instruction in laboratory methods and procedures.
- 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)
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
This is one of the biggest pharmaceutical companies that develops, produces and sells medicines.Role Description
You will support the value stream organizational structure and 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
Responsibilities
You are accountable for day to day testing activities in according with cGMP guidelines, and EHS SOP’s as well as Site manufacturing planning and agreed lead times.- Handling failure investigations.
o Timely management of (OOS) investigations, CAPAs, Regulatory commitment, GRAs, Audits, Global Standard implementation to ensure sustainable compliance.
o Write study protocol and report as part of failure investigations.
o Actively participate in advanced problem solving, root cause analysis, troubleshooting, interpretation/consultation, verification of quality and test results discussions.
o Effectuate agreed arrangements on deviations and reporting on progress.
o Support Complaints investigation by developing test methods and performing the test accordingly.
- Documentation
o Assistance in the establishment of standards, specifications, sampling plans, test procedures, or any other laboratory control mechanism.
o Assistance in the development and implementation of the quality control programs to ensure reliability of testing procedures, proper function of laboratory equipment and compliance with regulations; prepare and maintain applicable records.
o Handling in the preparation, review and finalization of specifications, standard test procedures and standard operating procedures.
o Participate in the development of new laboratory procedures and techniques; plan, develop and present workshops.
• Outsourcing
o Assistance in selection, audit & approval of contract laboratories.
o Managing outsourced QC laboratory activities (review, shipment, planning, progress, timely delivery).
• Qualification
o Maintain own technical expertise, personal skills and interpersonal skills needed to perform their duties in line with Site expectations.
o Demonstrate decision-making abilities in all aspects of performance.
o Trains and/or supervises training of other lab staff.
o Coordinate employees rotations to include instruction in laboratory methods and procedures.
Requirements
- HBO+ with several years of experience in a manager position in the pharmaceutical industry.- 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)
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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