Chemical Pharmaceutical company, located in area Lodi
Offerta
This position supervises a team of QC Analysts and reports to the QC Manager.
Supervise daily laboratory operations, ensuring laboratory personnel execute their responsibilities in strict accordance with relevant regulatory guidelines and internal procedures.
Provide direction to laboratory personnel internally and at contract laboratories to ensure timely release of the materials (raw materials, intermediate and final APIs).
Manage samples for analytical testing and the generation of results at external/contract laboratories.
Review and approval of the analytical work, including Stability Studies and Cleaning.
Support the issuing of internal SOP in accordance with the current Guidelines.
Ensure that laboratory personnel properly follow procedures and submit required documentation completely, accurately, and timely according to current cGMPs.
Maintain metrics for laboratory calibration, maintenance, and utilization of instrumentation and equipment.
Contribute to the continual improvement of all laboratory documentation to ensure they are current, accurate, and clearly define process and role responsibilities.
Support Laboratory Analysts in laboratory investigations (LIR, OOS, complaints) and in the implementation of effective CAPAs.
Competenze ed esperienza
Qualifications:
Degree
Minimum of 5 years relevant Quality Control experience.
Good knowledge of GMP guidelines and ALCOA+ principles
Demonstrate strong analytical laboratory skills in a variety of applications and the ability to troubleshoot for investigative purposes.
Knowledge of Empower 3 software
Completa l'offerta
Great career opportunity.
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