QA Release Specialist - GxP & Batch Release (Barcelona)

Novartis AG; Sabadell; Hybride; EUR 35 000 - 64 000; Plein temps

Avantages offerts par ce poste

Insurance plans

Retirement plans

Wellbeing resources

Global recognition programs

Flexible and hybrid working options

Minimum 14 weeks paid parental leave

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

QA/QC experience

GMP knowledge

Quality Assurance

Formation

Degree in Health Sciences

Description du poste

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.