Quality Assurance Release Officer

Novartis; Sabadell; Hybrid; EUR 35,000 - 64,000; Full time

Benefits offered by this job

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Flexible and hybrid working options

Minimum 14 weeks paid parental leave

Job summary

Novartis AG in Barcelona, Spain, is seeking a Quality Assurance/Control professional to manage QA/QC projects, ensuring GMP-compliant operations and alignment with the company's Quality Management Systems.

The role includes reviewing batch documentation prior to QP release, initiating EU Batch Certificates, and evaluating transport conditions for temperature excursions, with a hybrid working arrangement where possible.

Qualifications

• 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.

Responsibilities

• 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.

Skills

QA/QC experience

GMP knowledge

Quality Assurance

Education

Degree in Health Sciences

Job description

Job Description Summary

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.

Salary Range:

€34,700.00 - €64,400.00

Expected Annual Base Salary Range for role: Spain: EUR 34,700 - 64,400

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

• insurance plans, retirement plans, wellbeing resources and global recognition programs.
• flexible and hybrid working options, where possible, and a minimum of 14 weeks paid parental leave.

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.

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.

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 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

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