Supervisor, Calibration & Requalification in Ferentino, Italy

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Thermo Fisher Scientific is currently seeking a Supervisor, Calibration and requalification to join our team in Italy. This is an exceptional opportunity for a bold and curious individual with confirmed experience in the pharmaceutical industry. As the Supervisor, you will play a key role in ensuring the accurate calibration and requalification of equipment and plants, rigorously following safety regulations and company procedures.

Specific tasks/primary activities:

• Ensure the efficient organization of calibration and requalification activities through the supervision of the employee structure, rigorously following corporate regulations and procedures. This includes providing adequate support for production to maintain equipment validation status and achieve planned targets.

• Ensure the accurate creation of programmed calibration plans for GMP instruments (excluding laboratory analytical instrumentation) and update the relevant database (paper/software) in compliance with procedures and business plans.

• Ensure the accurate creation of periodic Requalification plans for GMP equipment/plants in compliance with procedures and business plans.

• Review and update calibration and requalification procedures, coordinating with the relevant functions.

• Supervise calibration and requalification activities, making any required program changes resulting from plant and equipment supervision, in compliance with GMP, procedures, SOP department, and quality and production requirements.

• Ensure the accurate performance of calibration activities and, when required, coordinate with the Manager to engage external specialist companies for niche calibration, in strict adherence to quality standards, GMP, company procedures, SOPs, and safety regulations.

• Support the Manager in rationalizing and updating the list of service providers, defining quality standards in compliance with GMP, company procedures, SOPs, and production requirements.

• Ensure compliance with company quality standards by verifying and supervising the application of procedures related to calibration and re-qualifications activities. Report any non-compliance and promote continuous improvements to maintain the highest quality of products and services.

• Ensure the accurate reporting and opening of deviations and changes, following existing change control and deviation procedures, as required or found at GMP plants and equipment.

For the position is required:

• Bachelor’s degree in engineering or scientific subjects or equivalent experience, with a minimum of 3 years of confirmed experience in the pharmaceutical industry.

• Knowledge of GMP/FDA regulations.

• Proficiency in writing procedures.

• Familiarity with pharmaceutical plant/equipment.

• Proficiency in the main computer software used in the pharmaceutical field.

• Knowledge of both written and spoken English.

• Ability to relate to multiple people-functions.

About Thermo Fisher Scientific

Thermo Fisher Scientific is a world-class company at the forefront of scientific research and innovation. We are dedicated to enabling our customers to make the world healthier, cleaner, and safer. With a strong commitment to excellence, we strive to deliver detailed solutions that have a positive impact on society.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.