•Substitutes Quality Control Manager in case of absence.

• Develops or collaborates to develop annual budgets and operating plans to support the programs.

• Support the QC Manager in ensuring all Analysts’ training is relevant and up to date, including that of your own

• Support the QC Manager in coaching and mentoring the Junior QC Analysts as well as the QC Analysts.

• Executes the analysis of raw materials, intermediates, in process controls, finished products and stability programs using the available laboratory equipment according to methods described in internal procedures.

• Develops and validates or collaborates to development and validation of analytical methods and other procedures.

• Verifies the calibration of instrumentation and the validity status of the analytical standards before use and ensures regular maintenance and calibration of analytical instruments.

• Recommends, implements and monitors preventive and corrective actions to ensure that quality assurance standards are achieved as prescribed by the relevant procedure.

• In case of an anomalous analytical result, has the responsibility to apply the procedure for managing anomalies, OOT, OOS.

• Reports to the QC manager any deviation identified during work activity.

• Ensures that quality control documentation (logbooks, analytical reports, etc.) are completed in time and duly signed.

• Executes purchase of materials, equipment, and services for the Quality Control Labs, collaborating with other departments and external suppliers.
• Proposes procedural changes for continuous improvement in accordance with company rules and cGMPs.

• Collaborates with Contract Laboratories and other outside entities;

• Participates in training, meetings and other activities, as defined by the Management, Control and Reporting System (MCRS).

• Performs other related tasks assigned by his superior.