ATMP QA Release Officer

Job Description Summary

The ATMP QA Release Officer assists the Qualified Person in maintaining and developing the quality assurance system and is responsible for the preparation and review of relevant documents in the context of the release of medicinal products by the Qualified Person.

 

Job Description

Major accountabilities:

•  Support of the Qualified Person(s) in the field of ATMPs (commercial goods and clinical investigational preparations) as well as in the supervision of clinical trainees in accordance with §3 of the Licensing Regulations for Pharmacists.
• Compilation and preliminary review of documents from databases.
• Execution of the batch record review of the manufacturing documentation. 
• Compliance with GxP requirements and other legal regulations in EU as well as participation or implementation of GxP training / SOP training.
• Contacts/exchange of information with national and international functions (including CGT US, CGT CH, QA, supply chain, responsible persons in the countries, depot).
• Archiving of documents for clinical investigational medicinal products.
• Evaluation of pharmaceutical product complaints.
• Documentation and evaluation of deviations.
• Preparation and maintenance of quality accrual agreements.
• Regular contacts with Novartis manufacturing companies and third-party manufacturers.
• Participation in audits and inspections.

Minimum Requirements:

• Education: Degree in Pharmacy preferred, or related Health Care degree.
• At least 2 years of demonstrated experience in pharmaceutical industry, in manufacturing, QA and QC. Preferable experience in Advanced Therapy Medicinal Products. 
• Analytical thinking, flexibility in working with other functions, country organizations, as well as the ability to solve problems.
• Organizational talent, persuasiveness and the ability to communicate across departments (also internationally).
• Fluent English and Spanish, written and spoken.

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? https://www.novartis.com/about/strategy/people-and-culture

Join 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: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

You will receive: Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 27 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities. 

Commitment 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.

 

Skills Desired