QC/Microbiology Analytical Lead-Sampling/Method Transfer-BioPharma

PROCESS ENGINEERING SPECIALISTS PTE. LTD.; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

PES International is seeking a QC/Microbiology Analytical Lead to join our life sciences projects in Singapore. You will lead QC analytical and microbiology sampling activities, ensuring alignment with GMP milestones and project timelines.

You will provide technical leadership across analytical QC and microbiological testing, coordinate with CQV, Validation, Manufacturing, and Quality teams, and ensure readiness of equipment, methods and documentation for commissioning and start-up.

Qualifications

• Experience in QC analytical and microbiology testing within pharma/biopharma.
• Experience with new facilities, technology transfer or major capital projects.
• Strong knowledge of cGMP and data integrity principles.
• Ability to lead sampling strategies and coordinate with cross-functional teams.

Responsibilities

• Lead all QC analytical and microbiology sampling activities to meet project milestones and GMP requirements.
• Develop and execute sampling strategies for process, utilities and environmental monitoring, including cleaning validation and qualification/validation activities.
• Provide technical leadership across analytical QC and microbiological testing, including method transfer, verification and validation.
• Coordinate sampling and testing with CQV, Validation, Manufacturing, Engineering, MSAT and Quality teams.
• Ensure laboratory readiness: equipment, methods, documentation, consumables, sample management and testing capacity.
• Lead planning and coordination of sampling/testing during commissioning, qualification, PPQ and start-up.
• Review data and support resolution of OOS/OOT, deviations, investigations and CAPAs.
• Ensure sampling, testing and documentation comply with cGMP and regulatory requirements.
• Identify risks and drive resolution to protect project schedule and readiness.

Skills

QC Analytical

Microbiology

GMP Compliance

Data Integrity

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.

We are currently looking for aQC/Microbiology Analytical Leadto join us on a permanent role to help us deliver various projects in the Life Sciences Industry.

Key Attributes/Responsibilities

• Lead allQC analytical and microbiology sampling activitiesfor the new project, ensuring alignment with project milestones and GMP requirements.
• Develop and execute sampling strategies forprocess, utilities, water/WFI, environmental monitoring, cleaning validation and qualification/validation activities.
• Provide technical leadership across bothanalytical QC and microbiological testing, including method transfer, verification and validation.
• Coordinate sampling and testing requirements withCQV, Validation, Manufacturing, Engineering, MSAT and Qualityteams.
• Ensure laboratory readiness, includingequipment, methods, documentation, consumables, sample management and testing capacity.
• Lead planning and coordination of sampling/testing duringcommissioning, qualification, PPQ and start-up.
• Review analytical and microbiological data and support resolution ofOOS/OOT, deviations, investigations and CAPAs.
• Ensure all sampling, testing and documentation comply withcGMP, data integrity and applicable regulatory requirements.
• Identify sampling/testing risks and constraints and drive timely resolution to protect theoverall project schedule and operational readiness.
• Require strong pharmaceutical/biopharmaceutical experience acrossboth QC Analytical and Microbiology, ideally within a new facility, technology transfer or major capital project environment.

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.