Quality Control Senior Analyst

Sanofi Aventis Singapore Pte. Ltd; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Sanofi Aventis Singapore Pte. Ltd. is seeking a Quality Control Senior Analyst to work on-site in Singapore, performing microbiological testing and sampling with shift support to ensure timely and compliant results.

You will contribute to water sampling, environmental monitoring, document control, and collaboration with QA to meet regulatory and quality targets while training new staff.

Qualifications

• Bachelor's degree or diploma in Pharmaceutical Sciences, Chemistry, Biology or related life sciences or technology.
• 4–6 years of experience in QC laboratory operations and microbiological testing.
• Knowledge of microbiological methods including microbial identification and clean utilities testing.
• Experience with pharma/biotech industry quality systems and data integrity.

Responsibilities

• Perform microbiological testing (Bioburden, Endotoxin, Growth Promotion Test, Microbial Identification, etc.) for samples.
• Perform water sampling of clean utilities system and environmental monitoring of controlled areas.
• Support general laboratory activities, including housekeeping and staging of chemicals, reagents, and consumables.
• Perform laboratory equipment maintenance and cleaning as required.
• Participate in continuous improvement to enhance safety, efficiency, compliance and metrics.
• Author/revise QC documents such as SOPs.
• Support deviation investigations and CAPAs, identify root causes and corrective actions.
• Train newcomers for QC laboratory activities and testing.
• Contribute to lab performance targets and metrics, including deviation/OOS rates and turnaround times.
• Support inspections and audits by Health Authority and internal/external audits.

Skills

Quality control

Microbiological testing

GxP compliance

Documentation

Education

Bachelor’s or Diploma in Pharmaceutical Sciences / Chemistry / Biology or related life sciences

Tools

LIMS

Job description

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 Senior Analyst to participate and contribute in testing, sampling and other laboratory activities on site. This role requires the personnel to support shift hours.

Main responsibilities:

• Perform microbiological testing (Bioburden, Endotoxin, Growth Promotion Test, Microbial Identification etc) for water, raw material and product samples
• Perform water sampling of clean utilities system and environmental monitoring of controlled areas
• Support general laboratory activities, including housekeeping and staging of chemicals, reagents, and consumables
• Perform laboratory equipment maintenance and cleaning as and when required
• Participate and contribute to laboratory continuous improvement to enhance safety, operational efficiency, compliance and performance metrics
• Author/ revise QC related documents such as SOPs
• Support deviation, investigation and unexpected events writing as and when necessary, identify root cause and appropriate corrective and preventive actions
• Train newcomers for QC laboratory activities and testing
• Contribute to the achievement of laboratory performance targets and key metrics, including deviation/OOS rates and sample turnaround times
• Support the team during Health Authority inspections and internal or external audits

Education and experience:

• Bachelor’s Degree or Diploma in Pharmaceutical Sciences, Chemistry, Biology or related life Sciences or Technology with 4 to 6 years of experience in QC laboratory operations and microbiological testing.
• Knowledge of microbiological methods, including microbial identification and clean utilities testing, in the pharmaceutical or biotechnology industry is required.

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 and communication skills
• Fluent in English speaking and writing

Pursue progress, discover extraordinary

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 and check out our Diversity Equity and Inclusion actions at sanofi.com!