QA Release Officer — GMP/Pharma | Hybrid (Barcelona)

(FCRS = US014) Novartis Pharmaceuticals Corporation; Barcelona; 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

14 weeks paid parental leave

Job summary

Novartis in Barcelona, Spain is seeking a QA Release Officer to ensure medicinal products meet regulatory and internal QC standards. You will review batch documentation and release for distribution, operating within GMPs and Novartis Quality Management Systems.

The role requires a health sciences degree, 1+ year QA/QC experience, native Spanish and good English, with hybrid work and a competitive benefits package.

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

GxP compliance

GMP knowledge

QA/QC experience

English proficiency

Spanish (native)

Education

Degree in Health Sciences

Job description

Novartis in Barcelona, Spain is seeking a QA Release Officer to ensure medicinal products meet regulatory and internal QC standards. You will review batch documentation and release for distribution, operating within GMPs and Novartis Quality Management Systems.

The role requires a health sciences degree, 1+ year QA/QC experience, native Spanish and good English, with hybrid work and a competitive benefits package.