Quality Control Specialist

Sanofi; Singapore; On-site; SGD 90,000 - 120,000; Full time

Job summary

Sanofi in Singapore is seeking a Quality Control Specialist to oversee Environmental Monitoring on site, ensuring cleanrooms and utilities meet cGMP standards. You will lead EM activities, collaborate with cross-functional teams, and drive data-driven improvements in monitoring programs.

The role requires a life sciences degree with 3–7 years of EM/GMP experience, strong documentation, and the ability to train personnel. Join a dynamic, global healthcare leader at the Tuas site.

Qualifications

• Bachelor’s or Master’s in pharmacy or life sciences with 3–7 years of experience.
• Experience with Environmental Monitoring programs and GMP.
• Strong documentation and data review skills.

Responsibilities

• Perform routine Environmental Monitoring (EM) activities, data review, trending, and documentation in accordance with GMP requirements.
• Develop EM sampling plans for routine monitoring, BSC EM sampling, isolator EM sampling, aseptic qualification, and equipment qualification activities.
• Coordinate EM sampling schedule to ensure all routine and ad hoc activities are completed on time.
• Review EM sampling results in LIMS to ensure data accuracy, completeness and GMP compliance.
• Forecast media requirements and provide procurement estimates for EM activities.
• Act as SME for Environmental Monitoring and provide guidance to EM personnel and cross-functional teams.
• Deliver EM training to ensure competency and compliance.
• Participate in cross-functional meetings to coordinate EM-related activities and provide input.
• Support EMPQ validation activities.
• Identify improvements to EM processes and team performance.

Skills

Environmental Monitoring

GMP compliance

Training delivery

Education

Pharma/related degree

Job description

Position: Quality Control Specialist

• Location: Tuas, Singapore

_ About the job: _

_ Our Company _

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s life. We turn the impossible in to the possible by discovering, developing and delivering medicines and vaccines for millions of people around the world.

The Sanofi Modulus is at the cornerstone of our strategy as it aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable and agile, leveraging new disruptive technologies, to better address biologics business challenges.

In this context, we are looking for one Quality Control Specialist to manage the Environmental Monitoring (EM) Program on site and contribute to related laboratory testing and support activities. This role ensures that manufacturing areas, cleanrooms and critical utilities are monitored, trended and controlled in line with cGMP, regulatory expectations and Sanofi quality standards.

Key Accountabilities

1. Environmental Monitoring Operations

• Perform routine Environmental Monitoring (EM) activities, data review, trending, and documentation in accordance with GMP requirements.
• Develop EM sampling plans for routine monitoring, BSC EM sampling, isolator EM sampling, aseptic qualification, and equipment qualification activities.
• Coordinate and manage the EM sampling schedule to ensure all routine and ad hoc activities are completed on time.
• Review EM sampling results in LIMS to ensure data accuracy, completeness, and compliance with GMP requirements.
• Forecast media requirements and provide procurement estimates to ensure sufficient inventory for EM activities.
• Act as the Subject Matter Expert (SME) for Environmental Monitoring, providing technical guidance and troubleshooting support to EM personnel and cross-functional teams.
• Serve as the EM trainer by developing and delivering training to ensure personnel competency and compliance.
• Participate in cross-functional meetings to coordinate EM-related activities and provide technical input.
• Support validation activities such as EMPQ
• Identify and implement improvement opportunities to enhance EM processes, efficiency, compliance, and overall team performance.

1. Gas monitoring Operations

• Coordinate with vendors for compressed gas sampling activities, including work permit arrangements and on-site support.
• Review gas sampling results in LIMS to ensure data accuracy, completeness, and compliance with GMP requirements.

1. Equipment & Qualification

• Lead equipment qualification and requalification (IQ/OQ/PQ) activities for EM equipment.
• Review and approve qualification documents, protocols, and reports.
• Manage the calibration of air samplers and particle counters, including scheduling, vendor coordination, and documentation.

1. Quality & Compliance

• Lead and support investigations related to EM excursions, deviations, contamination events, CAPAs, and change controls.
• Act as the document owner for EM-related SOPs, Work Instructions (WIs), and other GMP documents, ensuring they remain current and compliant.
• Manage the microbial isolate conservation program, including isolate selection, culture maintenance, and trending.
• Support the team during health authority inspections, internal and external audits as SME for Environmental Monitoring topics

_ About You: _

Education and experience

• Bachelor’s or Master’s Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology or related life Sciences or Technology with about 3-7 years of experience