Quality Control Specialist

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.
2\. 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.
3\. 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.
4\. 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 in QC laboratory operations and testing.
* Experience in environmental monitoring associated activities in the pharmaceutical or biotechnology industry is required.
* Knowledge of microbiological methods, including microbial identification and clean utilities testing, in the pharmaceutical or biotechnology industry is preferred.
Key technical competencies and soft skills:
* Knowledge of regulations and standards of the pharmaceutical industry
* Knowledge of the quality systems and associated technologies
* Good understanding of good laboratory practices, good documentation practice and data integrity requirements
* Strong interpersonal skills to foster effective cross-functional collaboration
* Discipline and assertiveness in the decision-making and execution in laboratory activities Good communication skills to advocate QC positions, including during inspections
* Fluent in English speaking and writing
Pursue _progress_, discover _extraordinary_
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Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our [ALL IN video](https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at [sanofi.com](https://www.sanofi.com/en/our-responsibility/equality-and…)!