Senior QC Specialist- BioPharma

efor (formerly process engineering specialists); Singapore; On-site; SGD 65,000 - 90,000; Full time

Job summary

PES International is seeking a skilled QC Specialist to provide technical support for QC activities related to new product introduction, analytical method validation, transfer, and equipment qualification. The role ensures laboratory readiness and compliance with GMP, pharmacopeia, and regulatory requirements within the Singapore QC lab.

You will work with local and global QC, MSAT, Manufacturing, QA, Validation, and project teams to deliver timely, compliant QC deliverables and support

Qualifications

• Lead QC activities for new product introduction and project-related QC work.
• Prepare and review protocols, transfer documents, validation reports, and GMP documentation.
• Assess method readiness, equipment qualification, and laboratory capacity for project success.
• Collaborate with cross-functional teams to ensure on-time, compliant project deliverables.

Responsibilities

• Provide QC technical support for analytical method validation and transfer.
• Lead method validation, verification, transfer, and method suitability activities.
• Support introduction of new analytical methods, lab processes, and equipment.
• Ensure QA documentation is accurate, inspection-ready and GMP compliant.
• Coordinate with project teams to track deliverables, timelines and risks.

Skills

QC knowledge

Analytical method validation

Method transfer

GMP compliance

Cross-functional collaboration

Documentation

Tools

Gen5 Secure

qPCR systems

Empower

Chromeleon

HPLC

GC/UPLC

Job description

PES is an international services company providing Project Management, Construction Management, Commissioning & Qualification and Automation services to our clients in the pharmaceutical, nutritional and related sectors.

With offices across Europe, Asia and US, our core focus is on consistently delivering high-quality outcomes for our multinational clients.

This focus, and our people's experience in delivering consistent quality results for our clients over the past 20 years has been key to our success to date.

Role Summary:

The QC Specialist / Senior QC Specialist will provide technical support for Quality Control activities related to new product introduction, analytical method validation, method transfer, method suitability, equipment qualification, and QC operational readiness.

The role will support new projects by ensuring that QC testing requirements, analytical method transfer strategy, method validation activities, laboratory readiness, analytical equipment qualification, documentation, and transition to routine QC operations are successfully completed in compliance with GMP, pharmacopeia, regulatory, and site quality requirements.

Key Responsibilities:

New Product Introduction & QC Project Support

• Provide QC technical support for new product introduction and project-related QC activities.
• Lead and coordinate QC activities related to analytical method validation, method verification, method transfer, and method suitability.
• Develop and execute analytical transfer plans, method transfer strategies, validation protocols, reports, and supporting technical documentation.
• Support the introduction of new analytical methods, laboratory processes, equipment, and technologies into the local QC laboratory.
• Ensure QC project deliverables are completed on time and in compliance with GMP, regulatory, pharmacopeia, and internal quality requirements.
• Work closely with local and global QC, MSAT, Manufacturing, QA, Engineering, Validation, and project teams to ensure successful project implementation.

Analytical Method Validation, Transfer & Suitability

• Lead analytical method validation, method verification, method transfer, and method suitability activities for new and existing products.
• Prepare and review technical protocols, method transfer documents, validation reports, risk assessments, gap assessments, and other GMP documentation.
• Support method development and validation activities for new analytical test methods introduced into the QC laboratory.
• Assess method readiness, laboratory capability, training needs, equipment availability, and analytical capacity for successful implementation.
• Support troubleshooting and investigation of method-related issues, atypical results, deviations, or technical challenges during project execution.

Bioanalytical & Microbiology Method Support

• Support QC project activities involving bioanalytical and microbiological methods, where applicable.
• Experience or knowledge in the following methods will be advantageous:
• Endotoxin testing
• Sterility testing
• qPCR
• Microbiological methods
• Other biological or analytical test methods used in pharmaceutical or biopharmaceutical QC laboratories

Analytical Equipment & Technology Introduction

• Support new analytical equipment introduction, equipment qualification, and technology implementation.
• Provide technical input for equipment requirements, qualification strategy, validation approach, and operational readiness.
• Knowledge or hands‑on experience with the following equipment and systems will be advantageous:
• rFC endotoxin plate reader with Gen5 Secure software
• qPCR systems
• Trans-Blot systems
• HPLC, GC, and UPLC systems
• Empower and/or Chromeleon chromatography software
• Support computerized analytical equipment qualification, data integrity assessment, and GMP documentation where required.

GMP Documentation & Compliance

• Write and review change controls, deviations, CAPA, events, SOPs, protocols, reports, and other GMP documents.
• Ensure documentation is accurate, technically sound, inspection‑ready, and aligned with site quality expectations.
• Apply GMP, GDP, data integrity, ALCOA+, pharmacopeia, and regulatory requirements in all QC project activities.
• Support audit and inspection readiness for QC‑related project deliverables.
• Ensure compliance with applicable safety, laboratory, quality, and security policies.

QC Operational Readiness & Lifecycle Transition

• Plan and support the transition of QC activities from project phase to routine operations.
• Ensure effective knowledge transfer, training, and documentation handover to routine QC testing teams.
• Develop training plans for new test methods, analytical equipment, and laboratory procedures.
• Support laboratory capacity planning, method readiness, equipment readiness, and resource planning for routine QC operations.
• Support lifecycle management activities following successful project implementation.
• Coordinate with project stakeholders to track QC deliverables, timelines, risks, issues, and dependencies.
• Provide QC technical expertise and consultation to project teams.
• Support cost planning and tracking for QC‑related project items such as facility modification, analytical equipment, method transfer, and laboratory readiness.
• Ensure project spending and QC deliverables remain aligned with approved project scope and budget.

We are currently looking for candidates in Singapore.

PES International operates as an equal opportunity employer. No terminology in this advert is intended to discriminate on the grounds of age, race, religion, sexual orientation or any other factors with no bearing to employment skills and we confirm that we are happy to accept applications from persons of any background for this role.