Sanofi
healthcare
BatchReleaseLead
Neural analysis suggests this role is
optimal for Mid candidates.
“Batch Release Lead at Sanofi. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement, deviation management, batch release processes, Good Manufacturing Practices (GMP). Investigating and resolving any issues or deviations related to batch release. Monitoring and analyzing quality performance metrics, implementing corrective actions as needed”
What You'll Achieve.
ensure compliance with local and international regulations; allow the decision for disposition of lots; enhance deviation investigation and progress monitoring process and effectiveness; Ensuring all batch release activities comply with Good Manufacturing Practices (GMP)
Industry & Context.
Investigating and resolving any issues or deviations related to batch release; Leading root cause analysis investigations for quality incidents and implementing preventive measures.; Capability to investigate and resolve issues or deviations efficiently
What They're Looking For.
Must Have
At least 5 years of experience in a QA role within the pharmaceutical industry, with a focus on deviation management, change control, and batch release processes, knowledge of Good Manufacturing Practices (GMP) and quality assurance principles
What You'll Do.
Investigating and resolving any issues or deviations related to batch release
Monitoring and analyzing quality performance metrics
implementing corrective actions as needed
Leading root cause analysis investigations for quality incidents and implementing preventive measures.
Collaborating with regulatory support officer to ensure compliance with local and international regulations
Participating in Quality Alert/Product alert meetings and ensuring that investigation and actions taken during those meetings allow the decision for disposition of lots
Point of contact within operational team for complaint investigation when needed on site (coordination of investigation report).
Implementing continuous improvement initiatives to enhance deviation investigation and progress monitoring process and effectiveness
Overseeing review and approval of batch records and associated documentation. Ensuring all batch release activities comply with Good Manufacturing Practices (GMP).
Participating in internal and external audits and inspections.
How You'll Work.
Team & Collaboration
cross-functional coordination; Collaborating with regulatory support officer to ensure compliance with local and international regulations; Participating in Quality Alert/Product alert meetings; Point of contact within operational team for complaint investigation when needed on site (coordination of investigation report).; Participating in internal and external audits and inspections.
Process & Methodology
managing multiple tasks and projects simultaneously
Full Job Description
**Position: Batch Release Lead** * Hiring Manager: Head of Quality Assurance Operation Unit APU * Location: Tuas, Singapore **About the job:** We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. Sanofi has added two new Modulus Facilities to our global industrial footprint. These production units represent the future of manufacturing. They allow us to increase our capacities while making production more flexible and respectful of the environment. Fully digitalized, our Modulus Facilities will enable more responsive and flexible manufacturing across multiple vaccine and biological platforms including mRNA, while minimize our impact to the environment. These facilities will help improve people’s lives by giving them faster access to more treatments. **Main responsibilities:** * Investigating and resolving any issues or deviations related to batch release * Monitoring and analyzing quality performance metrics, implementing corrective actions as needed * Leading root cause analysis investigations for quality incidents and implementing preventive measures. * Collaborating with regulatory support officer to ensure compliance with local and international regulations * Participating in Quality Alert/Product alert meetings and ensuring that investigation and actions taken during those meetings allow the decision for disposition of lots * Point of contact within operational team for complaint investigation when needed on site (coordination of investigation report). * Implementing continuous improvement initiatives to enhance deviation investigation and progress monitoring process and effectiveness * Overseeing review and approval of batch records and associated documentation. Ensuring all batch release activities comply with G
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