Facilities Deviation Writer (Guamúchil)

Facilities Deviation Writer (Guamúchil)

14 oct
|
Novartis
|
Guamúchil

14 oct

Novartis

Guamúchil

Band
Level 3

Job Description Summary
LI-Hybrid
Location: Mexico City, Mexico
Relocation Support: This role is based in Mexico City, Mexico. Novartis is unable to offer relocation support: please only apply if accessible.

Take ownership of quality where it truly matters - at the intersection of facilities, engineering, and patient impact. In this role, you will play a key part in ensuring deviations are thoroughly investigated, understood, and resolved, helping to maintain high standards in a complex GMP environment. You’ll work closely with cross-functional teams to drive robust investigations and meaningful corrective actions, while shaping a culture of continuous improvement and quality excellence. If you enjoy combining analytical thinking with hands-on collaboration, this role offers a chance to make a real difference.

Job Description
Key Responsibilities
• Open and assess deviations within required timelines, ensuring accurate classification and documentation

• Evaluate product impact of deviations, aligning with batch release requirements and quality standards

• Author, own,



and drive investigations through to timely and compliant closure; update SOPs as relevant to Deviations/CAPAs

• Apply structured root cause analysis methods to identify causes of process and product deviations

• Ensure investigations are complete, accurate, and fully supported with robust documentation

• Design and execute experiments or studies to support investigation outcomes

• Collaborate cross-functionally to assess deviation impact and maintain compliant operations

• Develop, document, and implement effective corrective and preventive actions

• Monitor CAPA effectiveness and ensure execution through Good Manufacturing Practice systems and training

• Deliver training and communication to reinforce quality practices and maintain compliance

Essential Requirements
• Bachelor’s degree in a relevant field with pharmaceutical industry experience

• Fluency in written and spoken

📌 Facilities Deviation Writer (Guamúchil)
🏢 Novartis
📍 Guamúchil

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