Quality Assurance Release Officer

DTX Pharma, a Novartis Company; Barcelona; Ibrido; EUR 35.000 - 64.000; Tempo pieno

Vantaggi offerti da questo lavoro

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Hybrid working

14 weeks parental leave

Descrizione del lavoro

DTX Pharma, a Novartis Company, in Barcelona is seeking a QA Release Officer to ensure that medicinal products meet manufacturing, testing, and distribution requirements in line with legislation and MA conditions.

You will review samples and documentation, release for distribution, and support GMP/GxP compliance across QA activities, reporting monthly indicators and managing archives.

Competenze

• Degree in Health Sciences is required.
• 1+ years of experience in Quality Assurance and/or Quality Control.
• Strong knowledge of GMPs and pharmaceutical manufacturing processes.
• Native Spanish and good level of English.

Mansioni

• Managing Quality aspects and projects within the area of responsibility.
• Ensuring and supporting overall GxP compliance and compliance with Novartis Quality Management Systems.
• Performing batch documentation review prior to release by the QP.
• Initiating and obtaining the EU Batch Certificate for centrally authorized products.
• Assessing the transport of commercial medicinal products and evaluating cases involving temperature excursions.
• Managing and prioritizing urgent requests and releases.
• Managing the reconditioning of commercial batches in compliance with GMPs.
• Ensuring the implementation of SLC in collaboration with Supply, DRA, and other related departments.
• Reporting and following up on monthly indicators, as well as managing the documentation archive and sample archive.

Conoscenze

Quality Assurance

Quality Control

GxP compliance

Formazione

Degree in Health Sciences

Descrizione del lavoro

Salary Range:
€34,700.00 - €64,400.00

Band
Level 3

Job Description Summary
#LI-Hybrid
Location: Barcelona, Spain.

This role is based in Barcelona, Spain. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

The QA Release Officer ensures that commercial medicinal products placed on the market comply with manufacturing, testing, and distribution requirements in accordance with current legislation and internal procedures, as well as with the conditions established in the Marketing Authorization for the medicinal product issued by the Health Authorities.

Responsible for the review of samples and related documentation. Responsible for Release for Distribution.

Job Description

Major Accountabilities:

• Managing Quality aspects and projects within the area of responsibility.
• Ensuring and supporting overall GxP compliance and compliance with Novartis Quality Management Systems.
• Performing batch documentation review prior to release by the QP.
• Initiating and obtaining the EU Batch Certificate for centrally authorized products.
• Assessing the transport of commercial medicinal products and evaluating cases involving temperature excursions.
• Managing and prioritizing urgent requests and releases.
• Managing the reconditioning of commercial batches in compliance with GMPs.
• Ensuring the implementation of SLC in collaboration with Supply, DRA, and other related departments.
• Reporting and following up on monthly indicators, as well as managing the documentation archive and sample archive.

Obligatory Requirements :

• Degree in Health Sciences.
• 1+ years of experience in Quality Assurance and/or Quality Control.
• Strong knowledge of GMPs and pharmaceutical manufacturing processes.
• Native Spanish and good level of English.

Rewards

At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.

• The rewards of being part of our team go far beyond base pay and incentives.We also offer a variety of competitive benefits inkindto help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeingresourcesand global recognition programs. In addition, we provide flexible and hybrid working options, where possible, anda minimum of14 weekspaid parental leave.

Expected Annual Base Salary Range for role:

- Spain: EUR 34,700 – 64,400

The salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.

In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. Further details will be provided during the application process.

Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.

Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.

Commitment to Diversity and Inclusion / EEO paragraph:

Novartis is committed to building an outstanding, inclusive work environment and diverseteams’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,supportingand 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

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

Skills Desired