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
- Bioburden 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.
Project Coordination & Cost Awareness
- 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.
If you'd like to find out about this opportunity or any other opportunity, please forward your CV to Nelson Anthony ([Confidential Information]).
To know more about the latest Jobs and Projects we are involved in, please follow us on LinkedIn at https://www.linkedin.com/company/processengineeringspecialists/mycompany/
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.
