At Kedrion, we believe that innovation and care must go hand in hand. Our mission is to enhance lives through our dedicated work in the field of rare and ultra-rare diseases.
As a global leader with a passionate team of 5,200 employees, we collect and fractionate plasma to produce and distribute 38 vital medicines worldwide, establishing ourselves as the fifth largest player in the plasma-derived products sector.
Job Summary
Supports the definition and maintenance of quality standards related to manufacturing activities (manufacturing, packaging, and distribution) and Sterility Assurance at Group level, in compliance with applicable regulations and corporate quality standards.
What you'll do
- Contribute to the development and implementation of global Manufacturing Compliance and Sterility Assurance policies, ensuring effective deployment and training across Group Manufacturing functions.
- Perform GMP audits at Group manufacturing sites and Contract Manufacturing Organizations (CMOs), in coordination with local Quality Assurance, Validation and Sterility Assurance teams.
- Review and assess manufacturing process transfer protocols to ensure compliance with internal procedures and applicable GMP requirements.
- Support industrialization activities for new manufacturing processes, ensuring readiness and robustness of quality documentation.
- Coordinate and/or support inter-site and external technology transfers (processes and equipment), ensuring appropriate documentation, effective project execution and adherence to defined timelines.
- Provide QA support to manufacturing sites for equipment and system qualification (IQ/OQ/PQ), process validation review, and assessment of changes, deviations and investigations within scope.
- Review qualification outcomes following the installation of new equipment and systems.
- Review and approve validation packages related to transport, cleaning and manufacturing processes, including Continuous Process Verification (CPV).
- Monitor evolving regulations and GMP guidelines and drive the implementation of updates into global procedures and standards.
- Apply and promote Quality Risk Management (QRM) principles, delivering training and ensuring correct use of risk assessment tools across functions.
- Support sites during regulatory inspections and internal or external audits, acting as Subject Matter Expert (SME) for Manufacturing Compliance and Sterility Assurance topics.
- Contribute to compliance projects linked to regulatory updates, including gap assessments and remediation plans.
- Develop and deliver training programs on Manufacturing Compliance and Sterility Assurance.
- Promote aseptic best practices to support harmonization and standardization across the Group.
- Support the evaluation and implementation of new technologies aligned with Quality by Design (QbD) principles.
Qualifications and need-to-know
- Degree in Pharmacy, Chemistry, Biology, or a related scientific discipline.
- Experience in GMP environments within manufacturing, quality assurance, validation or sterility assurance.
- knowledge of GMP regulations and guidelines related to sterile and non-sterile manufacturing processes.
- Proven ability to work in cross-functional.
- Strong analytical, organizational and documentation skills.
- Fluent English
This announcement is addressed to applicants of both sexes (L. 903/77 - D.Lgs n. 198/2006) and also to those belonging to Protected Categories (L.68/99).