Quality Investigator
Descrizione dell'offerta
Purpose of the Role
We are looking for a Quality Investigator who controls and verifies that all compliance requirements, both internal and external, are met before the finished product is delivered to the customer.
Key Responsibilities
• Performs quality event investigation steps in accordance with current procedures.
• Completes investigation reports and defines corrective and preventive action plans.
• Supports various departments in the initiation of quality events.
• Prepares investigation reports related to market complaints, determining the necessary analyses based on the type of complaint received.
• Collects quantitative and qualitative data from various operational areas for analysis and evaluates trends.
• Initiates, reviews, monitors, and tracks all deviations and CAPAs across the site to ensure timely and proper closure.
• Verifies SAP blocks on batches impacted by major deviations.
• Collects data related to investigation team metrics/KPIs.
• Collaborates during Authority and Client inspections.
Required Qualifications
• Degree in Pharmaceutical Chemistry and Technology (CTF) or a scientific background.
Technical Skills
• Good knowledge of GMP standards and FDA requirements.
• Familiarity with aseptic manufacturing processes.
• Good command of both spoken and written English.
Soft Skills
• Leadership, problem-solving, teamwork, analytical thinking, and attention to detail.
This announcement is addressed to all sexes, pursuant to laws 903/77 and 125/91, and to people of all ages and all nationalities, pursuant to legislative decrees 215/03 and 216/03.
By applying for this announcement, you authorize the processing of personal data pursuant to art. 13 of Legislative Decree no. 196 of 30 June 2003 - "Code regarding the protection of personal data" and art. 13 GDPR 679/16 - "European Regulation on the protection of personal data".