Senior Qualified Person (QP)

Overview

Adecco Italia Spa_Life Science is seeking a highly qualified Qualified Person (QP) for a pharmaceutical company operating in the development and manufacturing of semi-solid and liquid dosage forms.

Required Qualifications

• A degree in scientific disciplines such as Chemistry and Pharmaceutical Technologies, Pharmacy, Chemistry, Industrial Chemistry, Biological Sciences, Medicine and Surgery, or Veterinary Medicine.
• 10 years of significant professional experience, ideally within the chemical-pharmaceutical industry, with a strong background in quality management systems and GMP standards.
• Proven eligibility to practice as a Qualified Person, certified by AIFA (art. 52 Legislative Decree 24 April 2006 n. 219), and registration in the relevant professional register.
• A solid track record in coordinating and managing QA and QC departments, including resource planning and activity oversight.
• Advanced proficiency in the MS Office suite.
• Fluency in English, both spoken and written.

Job Responsibilities

• Oversee and manage Quality Assurance and Quality Control operations, ensuring optimal resource allocation and adherence to industry regulations.
• Ensure the analysis and market release of each batch in compliance with GMP standards and legal requirements, both in Italy and in destination countries.
• Maintain the site's production authorization by ensuring all production activities meet regulatory requirements.
• Collaborate on development plans, focusing on the integration of new products and technologies while maintaining regulatory compliance and obtaining necessary authorizations.
• Oversee the review and update of production-related documentation and the execution of stability studies in alignment with ICH guidelines.
• Foster collaboration between departments, including Quality, Production, Supply Chain, and Warehouse, to ensure seamless operations.
• Serve as the primary liaison with the Ministry of Health/Italian Medicines Agency (AIFA), supporting inspections and managing regulatory interactions.
• Promote the professional development of team members, evaluating performance and providing recommendations for recognition in line with company policies.

Work Location: Northern Province of Milan, Italy

Additional Notes: This is a full-time, permanent position offering a competitive salary and an attractive benefits package, including a company car.

Working Hours: Standard business hours.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Quality Assurance

Industries

• Pharmaceutical Manufacturing