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".