Qualified Person
Descrizione dell'offerta
Independently supervise manufacturing processes and control testing at the site related to the drug manufacturing license, operating as a Qualified Person according to local law (Article 52 of Legislative Decree n. 219 of April 24th 2006, from EU directive 2001/83/EC and subsequent modifications). Ensure compliance with the quality of medicinal products, the National Medicines Law, and other applicable regulations, maintaining an effective GMP-compliant quality system in collaboration with the Site Quality Head and Site Manager.
As part of Quality Assurance, support all GMP-relevant tasks (operational and strategic) by ensuring compliance with internal quality standards, relevant regulatory requirements, filed product quality standards, and SOPs.
Job Description
Major accountabilities :
- Guarantee and certify that each batch of medicines is produced and checked in compliance with the law and marketing authorization conditions.
- Assess and release manufactured medicinal products in accordance with national legislation.
- Ensure that documentation attesting the suitability of each product lot is available and can be presented to health authorities upon request.
- Collaborate in the approval of deviation investigations.
- Ensure proper storage and availability of batch records for released batches for inspection by health authorities.
- Immediately communicate any substantial irregularities detected in marketed products to the national Health Authority (AIFA) and management.
- Work with Quality Control and Production departments on activities related to manufactured batches.
- Identify and propose technological and organizational improvements to enhance manufacturing quality, productivity, costs, and resource optimization.
- Collaborate with Function Managers to ensure the correctness of the Quality Management System.
- Manage deviations, complaints, change controls, and CAPA processes.
Essential requirements :
- Degree in Pharmacy, CTF, or Chemistry.
- Previous experience in a pharmaceutical manufacturing environment with an authorized Qualified Person certificate according to Legislative Decree n. 219/2006.
- Strong commitment to quality and awareness of quality issues.
- Clear and open communication to ensure smooth and safe daily production operations.
- Fluent in Italian and English.
Why Novartis : Helping people with disease and their families requires more than innovative science. It takes a community of passionate, smart people like you. Collaborate, support, and inspire each other to achieve breakthroughs that change patients' lives. Join our Novartis network and stay connected for future opportunities. We are committed to diversity and inclusion, building an outstanding, inclusive work environment.
Benefits and Rewards : Learn about how we support your personal and professional growth in our handbook.
Desired Skills : Continued Learning, Decision Making, GxP Industry Standards, Laboratory Excellence, Instrumentation, Managing Ambiguity, Organizational Savvy, Quality Control Testing, Sampling, Resource Management, Self-Awareness, Risk Taking, Technical Knowledge, Total Quality Management (TQM).
Key Skills
Accounts Management, Facilities Management, Law Enforcement, Administration Support, ERP, Development.
Employment Type : Full-Time
Experience : Years
Vacancy : 1
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