Job Description Summary
The Shift Lab Supervisor manages Quality aspects and projects within area of responsibility.
Job Description
Major accountabilities:
Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance.
Define, in collaboration with your manager, the planning (weekly/monthly) and scheduling (daily) of laboratory activities.
Proactively support the team in analytical activities, continuous improvement, and “right first time” (Lean Lab).
Perform review of analytical documents and analytical approval of batches, verifying that analytical activities are executed and documented according to the current Testing Monographs and that analytical tests are performed on equipment properly qualified and calibrated according to their respective programs.
Ensure proper management of reagents, materials, and standards (adequate stock and storage per current procedures), coordinating material procurement requests, monitoring costs, and proposing any containment actions.
Perform, if necessary and according to prescribed methods, chemical, physico-chemical, microbiological, classical and/or instrumental analyses on substances examined within the assigned laboratory, across multiple products and using a wide range of complex and diverse equipment, in full compliance with HSE and cGMP standards.
Ensure correct entry of analytical data under your responsibility into the quality control management system (LIMS – Laboratory Information Management System).
Support, including through external suppliers, IQ/OQ/PQ activities for laboratory equipment (Installation/Operational/Performance Qualification).
Staff training.
Support exception investigations and OpEx improvement projects.
Essential requirements:
Scientific degree.
Previous experience in a similar role within a GMP laboratory.
Proven people management skills.
Knowledge of IT Applications & Quality tools.
Fluent in Italian and English.
Skills Desired
Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gxp, Industry Standards, Laboratory Equipment, Laboratory Excellence, Quality Control (Qc) Testing, Quality Control Sampling, Self-Awareness, Technological Expertise, Total Quality Management