Quality Supervisor (Pharmaceutical)

at  Thermo Fisher Scientific

EDUCATION/REQUIREMENTS

• Pharmacy (Químicos Farmacéuticos TITULADOS )
• Qualification/s or similar experience in the area of quality assurance.

EXPERIENCE/SKILLS

• Knowledge of IMP process, preferably with management of protocols, key customers, and business objectives.
• Auditor Experience.
• Up-to-date knowledge of regulatory standards.
• Knowledge of country logistics requirements.
• Ability to analyze problems and define solutions.
• Ability to prioritize and support others.
• Good interpersonal, verbal and written skills

CAPABILITIES OR SKILLS

• Result focus
• Continuous improvement / Analytical skills
• Partnership with other areas
• Good communication
• Customer interaction
• Decision making

DUTIES AND RESPONSIBILITIES

• Proactively lead quality processes and policies to ensure compliance with FCS quality standards in Chile, Colombia, and Peru.
• Evaluate and analyse current processes and policies for continuous improvement.
• Drive a quality culture in every sector of the organization through good practices, training, and collaboration with all areas of the organization.
• Carry out batch record approval.
• Ensure that all processes are carried out in accordance with cGMP.
• Responsible for the management of change control activities and planned and unplanned deviations.
• Responsible for the investigation of customer complaints until their resolution, when required.
• Be in direct contact with customers regarding quality issues.
• Conduct internal audits according to SOP requirements and collaborate in regulatory, supplier, and customer audits.
• Promote continuous training of staff in Quality/GMP throughout the company.
• Approve and maintain local SOPs, forms, and policies for Clinical Logistics.
• Approve and support qualification and validation of controlled areas.
• Creation and maintenance of critical metrics.

SUPERVISORY RESPONSIBILITIES

Leading Quality Assurance team for Andean Region countries