Senior Qualified Person: GMP Compliance & Batch Release
IT58 (FCRS = IT058) Advanced Accelerator Applications Italy Srl
Ottieni una risposta da questo datore di lavoro — un curriculum e una lettera di presentazione perfettamente in linea con ciò che sta cercando.
Vantaggi offerti da questo lavoro
Descrizione del lavoro
Novartis seeks a highly qualified Qualified Person to oversee and ensure the compliance of manufacturing and quality control activities at the Ivrea site, Italy. You will supervise manufacturing processes and control testing in alignment with GMP and regulatory requirements, reporting to the Site Quality Head and Site Manager.
You will support the implementation and maintenance of a GMP-compliant Quality Management System, ensuring adherence to national medicines legislation, product quality
Competenze
- Degree in Pharmacy, Pharmaceutical Chemistry and Technology, or related scientific discipline.
- Strong understanding of GMP requirements and regulatory expectations.
- Proven experience as a Qualified Person in pharmaceutical sterile manufacturing.
Mansioni
- Certify and release medicinal product batches in compliance with GMP and MA conditions.
- Approve batch documentation and records for inspection.
- Review and approve deviations, complaints, CAPAs, and related investigations.
- Collaborate with QA and Production to support batch-related activities.
- Escalate significant quality issues to site management and authorities.
Conoscenze
Formazione
Descrizione del lavoro
Novartis seeks a highly qualified Qualified Person to oversee and ensure the compliance of manufacturing and quality control activities at the Ivrea site, Italy. You will supervise manufacturing processes and control testing in alignment with GMP and regulatory requirements, reporting to the Site Quality Head and Site Manager.
You will support the implementation and maintenance of a GMP-compliant Quality Management System, ensuring adherence to national medicines legislation, product quality
'/%3e%3cpath%20d='M101.744%2012.4726L102.894%2016.1947L99.0021%2013.2201L101.744%2012.4726ZM105.3%208.40937H100.488L99.0026%203.59473L97.5116%208.41047L92.7%208.40385L96.5965%2011.3834L95.1055%2016.1942L99.0021%2013.2196L101.408%2011.3834L105.3%208.40992V8.40937Z'%20fill='white'/%3e%3cdefs%3e%3clinearGradient%20id='paint0_linear_5593_1381'%20x1='90'%20y1='9.44471'%20x2='99'%20y2='9.44471'%20gradientUnits='userSpaceOnUse'%3e%3cstop%20stop-color='%2300AD70'/%3e%3cstop%20offset='0.998594'%20stop-color='%2300B67A'/%3e%3cstop%20offset='1'%20stop-color='%23DCDCE6'/%3e%3c/linearGradient%3e%3c/defs%3e%3c/svg%3e){kind=small}
