Quality Assurance Officer

Novartis; Zaragoza; Presencial; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

A leading pharmaceutical company in Zaragoza seeks a QA Officer to oversee GMP activities and ensure quality compliance. Responsibilities include managing hygiene conditions, supporting batch release, and maintaining GMP documentation. Candidates should have a scientific degree and 1+ years in a Quality department. Fluency in English is required. This role offers an opportunity to contribute to high standards in pharmaceutical production.

Formación

• Scientific degree in Pharmacy, Chemistry or Biology.
• 1+ years of experience in a Quality department.
• Strong affinity with and awareness of Quality issues.
• Good organizational skills including attention to details.
• Solid knowledge of quality system (GMP) and basic knowledge of regulatory requirements.
• Fluent English verbally and in writing.

Responsabilidades

• Supervise the general conditions of hygiene of the premises.
• Contribute in assuring the validation/qualification status of the production site.
• Responsible for the provisional release for the shipment of batches.
• Work in shift with other QA officers.
• Archiving and managing the site GMP documentation.
• Contribute in maintaining the local quality system as per GMPs.
• Support the QP in the preparation of batch release documents.
• Collaborate in redaction of site GMP documentation.
• Support during external audits by the authorities.
• Participate in self-inspections and external audits.
• Ensure appropriate quality oversight during GMP activities.

Descripción del empleo

Summary

The QA Officer guarantees the quality oversight over the entire working time of the facility for all the GMP activities on going.

About The Role

Major accountabilities

• Supervise the general conditions of hygiene of the premises subject to its management
• Contribute in assuring the validation/qualification status of the production site, equipment, training of personnel and management of quality documentation
• Responsible for the provisional release for the shipment of batches
• Work in shift with other QA officers to oversight the production and quality control activities.
• Archiving and support in managing the site GMP documentation, review of batch records and assure the timely closure of the manufactured batches.
• Contribute in maintaining the local quality system as per GMPs and corporate guidelines and in assuring the respect of the GMPs and Health Authorities requirements at local level
• Support the QP in the preparation of batches release documents
• Collaborate in redaction of site GMP documentation and preparation and printing of batch documentation
• Support during the external audits by the authorities and corporate audits
• Collaboration in data compilation of Product Reviews, oversight on investigations and monitoring of resulting actions are checked and approved.
• Participate to the self-inspections as per approved annual plan and to the external audits
• Be responsible for the appropriate level of quality oversight during the GMP activities of the facility verifying they are executed according to the applicable standards in manufacturing, quality control, distribution and quality processes.

Minimum Requirements

• Education: Scientific degree in Pharmacy, Chemistry or Biology
• 1+ years of experience in a Quality department.
• Strong affinity with and awareness of Quality issues
• Good organizational skills including attention to details
• Solid knowledge of quality system (GMP) and basic knowledge of regulatory requirements
• Fluent English verbally and in writing

Why Novartis?

Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

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

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.

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