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Regulatory Compliance Associate

2 settimane fa


Ivrea, Piemonte, Italia Novartis Farmacéutica A tempo pieno

As a Regulatory Compliance Associate at Novartis Farmacéutica, you will play a vital role in ensuring the quality of our products. Your primary responsibility will be to analyze batches and incoming materials according to cGMP rules and SOPs.

About the Position

Main Responsibilities:

  • Analyze batches to ensure compliance with regulatory requirements.
  • Identify and report any deviations or out-of-specification results to the Quality Control Supervisor and Qualified Person.
  • Collaborate with the Quality Control Head/supervisor to implement corrective actions in response to non-compliance issues.
  • Maintain accurate records and documentation of batch analysis results.
  • Participate in CAPA implementation and execution in the quality control department.
  • Verify the quality of incoming and outgoing materials.
  • Support the Quality Control Head in managing material stocks and training new personnel.
  • Execute calibration, verification, qualification, and validation activities for Quality Control processes and equipment.

Essential Qualifications:

  • Degree in a relevant scientific field.
  • Previous experience in a GMP environment.
  • Ability to work flexible shifts, including night shifts.
  • Excellent command of Italian and good knowledge of English.