The QC Department must ensure the Quality Control of all materials, intermediates, final products, according to established specifications and GMP rules. The release of the product is done according to the mentioned rules and to support the QP release.
Specifically in QC Chemical Lab, your main responsibilities would be:
* Perform chemical and chemical-physical analysis, effectively and efficiently, for process controls, input materials, isolated intermediates and finished products, according to predefined plans and specifications, and company quality standards;
* Perform the analyses provided for in the stability plan;
* Validate and transfer analytical methods and demonstrate their correct application according to production and quality control requirements;
* Perform maintenance and calibration of instruments, drafting and/or revision of laboratory SOPs, instrument and process qualification protocols;
* Cooperate during the external/internal audits;
* Cooperate during the OOS investigations;
* Cooperate during the deviation investigations;
Qualifications
* Bachelor’s degree in Chemistry, Pharmacy or Chemistry and Pharmaceutical Technologies.
* At least 1-2 years of experience in the same role.
* Knowledge of GMP and GLP.
* Knowledge of the following analytical techniques:
* HPLC;
* Karl Fischer;
* Basic chemical laboratory equipment;
* SAP (nice to have).
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