Global Validation Lead – Pharma Process & Compliance

Novartis Corporation (M) Sdn Bhd; Selangor; On-site; MYR 90,000 - 130,000; Full time

Job summary

Novartis is seeking a Validation Specialist to develop and execute validation documentation and strategies for compliant manufacturing processes across global markets, including Singapore-related operations. The role emphasizes process and cleaning validation, cross-functional coordination, and timely execution.

You will review protocols and reports, lead investigations into deviations, and drive continuous improvement while ensuring adherence to quality systems and regulatory requirements

Qualifications

• Two to eight years of experience within a biopharmaceutical or pharmaceutical manufacturing environment.
• Strong understanding of manufacturing processes and associated production equipment.
• In-depth knowledge of quality systems and regulatory requirements across multiple health authorities.
• Experience executing process validation and/or cleaning validation activities in a regulated environment.
• Demonstrated expertise in technical report writing, document review, and cross-functional project management.
• Fundamental understanding of pharmaceutical analytical testing methods and laboratory practices.
• Fluency in Artificial Intelligence tools and technologies to support innovation and operational excellence.

Responsibilities

• Developing validation documentation to support compliant manufacturing processes and lifecycle management.
• Executing process and cleaning validation strategies aligned with regulatory and quality requirements.
• Coordinating validation activities with cross-functional teams to ensure timely and effective execution.
• Providing validation support for manufacturing processes serving global markets, including Singapore-related operations.
• Leading investigations and supporting resolution of validation deviations, observations, and technical issues.
• Reviewing and approving validation protocols, reports, risk assessments, and related technical documentation.
• Driving continuous improvement initiatives to enhance validation effectiveness, compliance, and operational performance.
• Managing validation projects and stakeholder engagement across multiple functions and sites.

Skills

Technical report writing

Cross-functional collaboration

AI tools fluency

Pharma analytical methods

Laboratory practices

Education

Bachelor's or Master's in Chemistry/Biological Sciences/Pharmacy

Job description

Novartis is seeking a Validation Specialist to develop and execute validation documentation and strategies for compliant manufacturing processes across global markets, including Singapore-related operations. The role emphasizes process and cleaning validation, cross-functional coordination, and timely execution.

You will review protocols and reports, lead investigations into deviations, and drive continuous improvement while ensuring adherence to quality systems and regulatory requirements