Position

Quality Control Bioassay Specialist

Published on 05/05/2022

Kalite ve Güvenlik

Kocaeli, TR-41

Job Description:

Wyser is the international company within Gi Group in charge of searching for and selecting specialized middle and senior management.


We are looking for "Quality Control Bioassy Specialist" to one of our business partners in pharmaceuticals industry.


Qualifications:

• Graduated from 4-year related departments of universities,

• Having a minimum of 2 years of experience,

• Having a detailed structure,

• Advanced level of English.


Job Description:

• Completion of analytical method transfer and validation processes,

• Preparation and review of documents such as Standard Test Methods, SOP, Method Validation Protocols and Reports, Certificates of Analysis in accordance with GMP,

• Completion of routine water and steam system analysis, in-process control, raw material, bulk product and finished product release analysis,

• Creation of stability protocols and reports, completion of stability analyzes and reporting,

• Supply of cell banks, creation of MCB and WCB and completion of qualification tests,

• In the process of method development and validation, batch release and stability; Conducting bioanalyses such as proliferation of different mammalian cell lines, proliferation tests, cytotoxic tests, cytostatic tests, CDC and ADCC tests,

• In the process of method development and validation, batch release and stability; Completion of ELISA, host cell protein, host cell DNA and mycoplasma tests,

• Working in accordance with the quality management system rules such as OOS, OOT, change controls and deviation, and completing the documentation,

• Follow-up of purchasing processes,

• Cooperation with the Quality Assurance and Engineering Department for routine needs.

Industrial sector

Reference code

1789

Consultant

Ezgi Seyhan, is our consultant who manages this job opportunity.

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