Senior Qualified Person (QP)

JR Italy; Varese; In loco; EUR 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

A leading consulting firm is seeking a Qualified Person (QP) to oversee Quality Assurance and Quality Control operations for a pharmaceutical company. The ideal candidate will have over 10 years of experience in the chemical-pharmaceutical industry, a degree in a scientific discipline, and proven GMP knowledge. This full-time position offers a competitive salary, benefits including a company car, and is located in Northern Province of Milan, Italy.

Servizi

Competitive salary

Company car

Attractive benefits package

Competenze

• 10 years of significant professional experience in the chemical-pharmaceutical industry.
• Certified eligibility to practice as a Qualified Person, registered with AIFA.

Mansioni

• Oversee Quality Assurance and Quality Control operations.
• Ensure compliance with GMP standards and legal requirements.
• Collaborate on development plans and integration of new products.

Conoscenze

Quality management systems

GMP standards

Coordination and management

MS Office proficiency

Fluency in English

Formazione

Degree in scientific disciplines

Descrizione del lavoro

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

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.