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On-site
Experience
Some experience
About the role
This role supports GMP operations and the validation team at a pharmaceutical site, handling quality systems such as change controls, validation, deviations, lab investigations and CAPAs. You will help with day-to-day batch record review, batch disposition and release, and continuous improvement work. It suits someone with quality operations experience in pharma who is detail-oriented, decisive and comfortable working with cross-functional teams.
What you'll do
Review batch records and related documentation, and oversee their review and approval
Oversee the batch release process so it meets regulatory and company standards
Make sure batch release activities follow Good Manufacturing Practices
Work closely with production to keep quality standards across the product lifecycle
Quality Assurance QA Specialist job at Sanofi, Singapore | WorkJio
Lead complex root cause investigations for batches affected by deviations or lab investigations, and review and approve them
Track and analyse batch release performance metrics
Monitor corrective and preventive actions to ensure they close on time, and work with site operations on prevention and system improvements
Drive continuous improvement initiatives to make batch release more efficient and effective
Represent the site in the global CoP and, if asked, take part in the CoE for batch release and handle local communication
Review qualification and validation documents such as protocols, reports, risk assessments and traceability matrices within set timelines, and ensure deviations, non-conformances and corrective actions are documented
Evaluate change controls from a validation perspective
Ensure qualification and validation activities meet regulatory requirements (e.g. FDA, EMA) and company quality standards
Run regular audits of production processes to find and address potential quality issues
Support internal and external audits and regulatory inspections with documentation
Develop and implement risk management strategies to reduce potential quality issues
Promote a culture of quality and continuous improvement across the organisation
Coordinate the Annual Product Review
Take part in GEMBA walk-downs during investigations to triage and resolve on-the-floor manufacturing issues
Complete all mandatory and related GMP training
Facilitate the daily level 2 quality meeting, back up the QA Executive, support the monthly joint GEMBA and back up QA Specialists
Follow HSE guidelines, embrace the Zero Incident Mindset and take responsibility under HSE protection policies and Life Saving Rules
Good to know
Full time role based in the City of Singapore
Decision-making involvement includes approving documentation for batch disposition, approving correctly completed batch records, checking practices against quality requirements, resolving issues and deviations, implementing remediation from audit findings, requesting quality improvement initiatives, identifying discrepancies and corrective/preventive actions, reviewing batch dispositio
Requirements
Engineering or Science degree or equivalent from a recognised institution
3–5 years of quality operations experience in the pharmaceutical industry, or equivalent education and relevant work experience
Experience in batch release, deviation and investigation handling is preferred
Quick learner with a proactive can-do attitude
Adaptable and flexible in managing rapidly changing priorities
Committed to supporting site activities in line with the manufacturing schedule
Apply on the company website
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