GMP Deviation & CAPA Specialist

Novartis; Guamúchil; Híbrido; MXN 500.000 - 750.000; Jornada completa

Descripción de la vacante

Novartis Mexico City is seeking an experienced quality investigator to lead deviation investigations and CAPA activities in a GMP environment. The role requires coordinating cross-functional teams, assessing product impact, and ensuring timely closure of investigations to maintain compliant production.

The candidate will work in a rotating shift with occasional weekend responsibilities, and will generate manufacturing orders as needed while delivering targeted training to enhance quality and

Formación

• Bachelor’s degree in a scientific field.
• 2–5 years of pharmaceutical industry experience.
• Experience in Good Manufacturing Practice production environment, preferably aseptic or sterile.
• Experience leading deviation investigations and CAPA activities.
• Strong knowledge of GMP regulations and regulatory expectations for pharmaceutical manufacturing.
• Fluent English and Spanish communication skills.

Responsabilidades

• Open and assess deviations, determining criticality within defined timelines.
• Evaluate product impact of deviations in alignment with batch release activities.
• Author and own investigations, ensuring clear scope, root cause, and timely closure.
• Apply structured root cause analysis tools to identify product and process deviations.
• Develop, document, and implement effective Corrective and Preventive Actions.
• Verify robustness and effectiveness of critical and major investigations.
• Execute experiments or manufacturing runs to support investigation outcomes.
• Collaborate cross-functionally to ensure compliant production during deviations.
• Generate manufacturing orders within the Manufacturing Execution System as required.
• Deliver targeted training to reinforce quality practices and compliance standards.

Conocimientos

Deviation investigations

Root cause analysis

GMP knowledge

Quality mindset

Bilingual English/Spanish

Educación

Bachelor’s degree in a scientific field

Descripción del empleo

Novartis Mexico City is seeking an experienced quality investigator to lead deviation investigations and CAPA activities in a GMP environment. The role requires coordinating cross-functional teams, assessing product impact, and ensuring timely closure of investigations to maintain compliant production.

The candidate will work in a rotating shift with occasional weekend responsibilities, and will generate manufacturing orders as needed while delivering targeted training to enhance quality and