Senior Method Validation & QC Lead

AMARIS GROUP SA; Singapore; On-site; SGD 110,000 - 170,000; Full time

Job summary

Amaris Consulting is seeking a Senior QC Specialist (Method Validation & Technical Support) to lead analytical method lifecycle activities in a GMP environment. You will oversee method development, qualification, validation, verification, transfer and lifecycle management for chemical and biological testing while ensuring equipment qualification and regulatory readiness.

You will drive CAPA, investigations, data review, and trend analysis, and collaborate with QC, QA, Manufacturing, Regulatory

Qualifications

• Bachelor's degree in a relevant field is required.
• Minimum 5 years in pharmaceutical/biopharmaceutical QC, analytical development, or technical support in GMP environments.
• Hands-on experience in method validation, transfer, qualification, verification and equipment IQ/OQ/PQ.

Responsibilities

• Lead analytical method qualification, validation, verification, transfer and lifecycle management for chemical and biological testing.
• Manage qualification of laboratory equipment, analytical instruments and critical reagents, ensuring GMP compliance.
• Support introduction of new methods, technologies, materials, and equipment into QC operations.
• Coordinate QC stability programs, including data review and trend analysis.
• Lead investigations of deviations, OOS/OOT, root cause analysis and CAPA implementation.
• Monitor regulatory and compendial updates to ensure GMP readiness under FDA/USP/EP/ICH guidelines.
• Author, review, and approve GMP documents including SOPs, protocols, reports and change controls.
• Act as SME and provide training and knowledge transfer to QC teams.
• Support internal and regulatory audits as SME for assigned areas.
• Drive continuous improvement to analytical methods, lab processes and efficiency.
• Collaborate with QC, QA, Manufacturing, Validation, Regulatory Affairs and Global Tech teams.

Skills

Analytical QC Leadership

GMP Compliance

Method Validation

Root Cause Analysis

Cross-functional Collaboration

Regulatory Awareness

Documentation

Technical Writing

Education

Bachelor's Degree in Chemistry/Biochemistry/Pharmaceutical Sciences

Tools

LIMS

CDS

Electronic QA Systems

Job description

Amaris Consulting is seeking a Senior QC Specialist (Method Validation & Technical Support) to lead analytical method lifecycle activities in a GMP environment. You will oversee method development, qualification, validation, verification, transfer and lifecycle management for chemical and biological testing while ensuring equipment qualification and regulatory readiness.

You will drive CAPA, investigations, data review, and trend analysis, and collaborate with QC, QA, Manufacturing, Regulatory