Senior QC Specialist (Method Validation & Technical Support)

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

Senior QC Specialist (Method Validation & Technical Support)

Permanent Job

Job Summary

The Senior QC Specialist (Method Validation & Technical Support) is responsible for providing technical and scientific leadership to Quality Control (QC) operations through the management of analytical method lifecycle activities, equipment qualification, investigations, compliance initiatives, and continuous improvement programs.

This role serves as a key technical Subject Matter Expert (SME) supporting method development, qualification, validation, verification, equipment qualification, compendial compliance, and regulatory readiness activities. The incumbent will work closely with routine testing laboratories to ensure analytical methods, equipment, and laboratory processes remain compliant with applicable regulatory requirements and industry best practices.

About the Job

• 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 compliance throughout their lifecycle.
• Support introduction of new methods, technologies, materials, and equipment into QC operations.
• Coordinate and maintain QC stability programs, including data review and trend analysis.
• Lead investigations of deviations, non-conformances, invalid results, atypical results, and OOS events; perform root cause analysis and drive CAPA implementation.
• Monitor and implement regulatory and compendial updates to ensure ongoing compliance with GMP, FDA, USP, EP, and ICH requirements.
• Author, review, and approve GMP documentation including SOPs, protocols, reports, change controls, deviations, and CAPAs.
• Act as a technical SME, providing guidance, training, and knowledge transfer to QC testing teams.
• Support internal audits, regulatory inspections, and customer audits as the SME for assigned areas.
• Drive continuous improvement initiatives to enhance analytical methods, laboratory processes, compliance, and operational efficiency.
• Collaborate with cross-functional teams including QC, QA, Manufacturing, Validation, Regulatory Affairs, and Global Technical functions.

About You

• Bachelor's Degree in Chemistry, Biochemistry, Biotechnology, Pharmaceutical Sciences, Life Sciences, or a related discipline.
• Minimum 5 years of experience in pharmaceutical or biopharmaceutical Quality Control, Analytical Development, or Technical Support functions within a GMP-regulated environment.
• Hands‑on experience in analytical method validation, qualification, verification, transfer, equipment qualification (IQ/OQ/PQ), stability programs, and laboratory investigations (OOS/OOT, deviations, CAPAs, and change controls).
• Strong knowledge of GMP requirements, analytical method lifecycle management, root cause analysis, GMP documentation, and global regulatory standards including FDA, USP, EP, ICH, PIC/S, and Data Integrity principles.
• Experience supporting regulatory inspections, audits, and acting as a technical Subject Matter Expert (SME) is highly preferred.
• Exposure to biologics, vaccines, sterile manufacturing, cell & gene therapy, LIMS, CDS, electronic quality systems, or laboratory digitalization initiatives is an advantage.
• Strong analytical, problem‑solving, technical writing, stakeholder management, and cross‑functional collaboration skills, with the ability to work independently, drive continuous improvement initiatives, and provide effective training and knowledge transfer.

Equal Opportunity

Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability or other characteristics.