drjobs Qualified Person

Qualified Person

Employer Active

1 Vacancy
The job posting is outdated and position may be filled
drjobs

Job Alert

You will be updated with latest job alerts via email
Valid email field required
Send jobs
Send me jobs like this
drjobs

Job Alert

You will be updated with latest job alerts via email

Valid email field required
Send jobs
Job Location drjobs

Ivrea - Italy

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Job Description Summary

Independently supervise without any interference of third persons manufacturing processes and control testing of the site related to the drug manufacturing license operating as Qualified Person according to the local law (Article 52 of the Legislative Decree n. 219 of April 24th 2006 from EU directive 2001/83/CE and following modifications). With respect to the quality of the medicinal products assurance of compliance to the National Medicines Law and other applicable regulations and together with the Site Quality Head and Site Manager maintaining an effective implementation monitoring and maintenance of a GMPcompliant quality system.

As Quality Assurance it is required to support all GMP relevant tasks/issues (operational and strategic) by ensuring compliance according to the internal quality standards relevant regulatory requirements filed product quality standards and SOPs in place.



Job Description

Major accountabilities:

  • Guarantee and certify that each batch of medicines is produced and checked in compliance with the law and the conditions imposed in the marketing authorization.

  • Assessment and release of manufactured medicinal products in accordance with national legislation.

  • Guarantee that the documentation attesting the suitability of each product lot is available and can be shown at the request of the health authority.

  • Collaborate in the approval of deviation investigations.

  • Make sure that the batch record of the released batch is stored correctly and can be exhibited at the request of the health authority.

  • Communicate immediately to the national Health Authority (AIFA) and to the Management any substantial irregularity detected in the product that has already been placed on the market.

  • Work in collaboration with Quality Control and Production departments in the activities related to the manufactured batches.

  • Identify and propose technological and organizational interventions aimed at improving manufacturing processes in terms of quality productivity and costs and the optimization of resources.

  • Collaborate with the Function Managers in order to guarantee the correctness of the Quality Management System.

  • Management od deviations complaints change control and CAPA.

Essential requirements:

  • Degree in Pharmacy CTF or Chemistry.

  • Previous experience in the role within a pharmaceutical manufacturing environment Authorized Qualified Person certificate according to Legislative Decree n. 219 of April 24th 2006.

  • Strong affinity with quality and awareness of quality issues.

  • Open and clear collaboration and communication to make sure the daily production operation runs smoothly and safely.

  • Fluent in Italian and English.

Why Novartis:Helping people with disease and their families takes more than innovative science. It takes a community of smart passionate people like you. Collaborating supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together our Novartis Network:Not the right Novartis role for you Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: to Diversity and Inclusion: Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.

Employment Type

Full-Time

About Company

Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.