Quality Control Analyst

Location: Netherlands

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!Our client is a professional Pharmaceutical organisation, based in Noord-Holland Netherlands.

The Company

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Role Description

Support the value stream organizational structure, take care of all non-routine Quality Control activities for example:
o Laboratory Quality Control Product Specialist (Knowledge of specific product characteristics)
o Lead of phase II OOS- en complex investigations
o Stability trending,
o Lab Outsourcing,
o Quality Analyst Job Training
o Equipment care (maintenance/validation/calibration)
o SME during Regulatory and client inspections

Responsibilities

• Accountable for day to day testing activities in according with cGMP guidelines, Teva Global Standard and local GMP as well as EHS SOP’s.
• Accountable for day to day testing activities in according with Site manufacturing planning and agreed lead times.

• Handling failure investigations.
o Timely management of (OOS) investigations, CAPAs, Regulatory commitment, GRAs, Audits, Teva 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.

Requirements

University level (Pharmacy / Analytical Chemistry) or HBO+ with several years of experience in a manager position in the pharmaceutical industry.

Specific Training (internal and / or external and experience
• 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)

Other information

In this role you are going to work in shifts:

7:00 - 15:30
15:00 - 23:30
23:00 - 7:30

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ravi Ramnarain Singh.