Quality Control Technician

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

This is your chance to work at an international company!

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

• Quality Control testing
o 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)
o Back-up for testing, approve or reject of the raw materials, packaging materials & finished products, stability samples as per the committed time lines.

Responsibilities

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

• 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.

• Stability:
o Handling stability studies as per the regulatory requirement.
o Timely preparation, review and approval of stability trend & evaluation reports.

• 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.

Requirements

- HBO
- 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

You will be working in shifts:
0700-1530
1500-2330
2300-0730

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.