Job Title:  API QUALITY ASSURANCE SPECIALIST

The purpose of the position is to ensure the correct surveillance of the Quality Management System of the Angelini Pharma chemical plant located in Aprilia, according to relevant cGMP, FDA 21 CFR Part 211 and Part 210, and ICH Q7 guideline, as applicable. The QA Specialist supports the implementation, maintenance, and continuous improvement of quality processes, ensuring that all site activities comply with internal procedures, regulatory requirements, and industry standards

MAIN RESPONSIBILITIES:

• Help the Manager in defining the Fine Chemicals Quality Management System.
• Ensure that the production activities and those connected to them, take place based on the quality parameters established by Good Manufacturing Practices (cGMP), by the Regulations in force and by the Company.
• Follow the Quality Policy, Quality Objective and Global standards into the Site Quality System; with this aim support the Manager to implement local standards for being compliant with Global aspects.
• Maintain up-to-date knowledge and ensure appropriate application of relevant cGMP, FDA 21 CFR Part 211 and Part 210 and ICH Q guidelines and local regulations/standards as applicable that impact the products manufactured.
• Propose procedures to ensure the quality of processes and products, referring to the Quality Regulations based on company specifications defined.
• Participate in process improvements to process of the Quality System.
• Ensure that the production activities take place and are monitored based on the established processes and standards.;
• Support the directly coordinated functions for the correct performance of Production and Control activities.
• Ensure documental verifications to confirm the conformity of production and control standards with Quality regulations.
• Ensure successful inspection. Actively participate toin internal and external audits, inspections, certifications and monitoring of associated CAPAs for manufacturing.

DESIRED PROFILE:

• Degree in Chemistry/Pharmaceutical Chemistry and Technology (CTF).
• Knowledge of the English language.
• Familiarity with Windows operating system and the Microsoft Office package.
• Previous experience in Quality Assurance in the area Quality system management will be considered a preferential qualification.
• Strong initiative.
• Teamwork skills.
• Motivation and determination to achieve objectives.
• Problem-solving abilities.
• Time management.
• Flexibility.

Angelini Pharma is an equal Opportunity Employee

We believe that diversity is a huge value that contributes to individual and company success.

We are committed to create a diverse and inclusive environment.