Manufacturing Process Leader

2 days ago


Klang, Selangor, Malaysia Novartis Full time
Job Description

At Novartis, we are seeking a highly skilled Manufacturing Process Leader to provide technical support for all manufacturing compliance and process-specific issues. This role will ensure the execution of processes on-time, in compliance with cGMPs, SOPs, and applicable guidelines.

About the Role:

  • Provide expert support for all quality and compliance issues related to production, act as a Subject Matter Expert (SME) for quality processes.
  • Coordinate and ensure the completion of all production operations on time, perform real-time batch follow-up and technical review, manage change-over activities, and ensure all production documents are up to date.
  • Execute training and education programs for operators, support the T&L organization in defining and maintaining qualification criteria, deliver instructor-led training, and promote Quality and HSE culture on the shop floor.

Responsibilities:

  • Lead area walkdowns, Gemba, and environmental monitoring governance on the shopfloor to identify and address facility maintenance, housekeeping, process, or personnel issues.
  • Collaborate with MS&T experts for multi-product risk assessments and validation strategy definition, prepare and support health authority and internal inspections, and collaborate with Regulatory Compliance QA for dossier submissions and revisions.
  • Manage GMP documentation, master manufacturing documents, and validation, revalidation, and qualification activities, periodic review of production unit equipment, and consistent reporting of trending and evaluation reports required.


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