QA Operations Officer - Novartis Group
  • Palafolls
descripción del trabajo

Growth is the engine powering everything we want to achieve for patients. It will allow us to innovate and pioneer greater access to high-quality medicines, but we can only do this by bringing the best and the brightest minds together. Our manufacturing site in Palafolls is expanding, so this is a unique opportunity for QA profiles to learn about develop new lines on site. Your responsibilities include, but not limited to: • Ensure that the documentation associated with the batch (BR, labeling, related records, and manufacturing conditions) have been reviewed, verifying that it has been manufactured according to the validated process. • Interpret and apply quality standards (Guides, Quality Manual, SOPs, etc.) in the business context to ensure compliance with GMP regulations in processes. Promote the implementation of a quality culture in all areas of the company. • Know the manufacturing processes, products and facilities assigned to their area of responsibility, as well as the procedures that apply. Promote their presence in the areas assigned to them to facilitate the implementation of the culture and quality standards in the organization. • Immediately escalate potential GMP or quality compliance issues in production processes. • Participate in the activities promoted by the Data Integrity Officer of the plant. Comply with and ensure compliance with Data Integrity requirements. • Participate in claim and return investigations as assigned. • Collaborate in internal and external audits (health authorities, corporate and clients). • Collaborate in the preparation and review of the documentation of your area, preparing the SOPs that describe the activities of your area of responsibility when assigned, having completed the corresponding training and keeping them up to date. Commitment to Diversity & Inclusion: We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. What you’ll bring to the role: • Education: Degree in Pharmacy is a must. Being Qualified Person will be highly valued • Languages: Fluent Spanish, good level of English is preferred. •Solid integrity and communication skills • Experiences: Experience in GMP regulations will be highly valued

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