Position: Quality Operations Expert II
Hiring Manager: Head of Quality
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 (including temperature excursion evaluation per product in case distribution channel face an unusual event)
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.
Skills and Experiences
Experience
At least 5 years of experience in a QA role within the pharmaceutical industry, with a focus on deviation management and batch release processes
Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance principles
Skills
Capability to investigate and resolve issues or deviations efficiently.
Ability to meticulously review batch records and documentation to ensure accuracy and compliance with regulatory standards.
Proficiency in analyzing performance metrics and identifying areas for improvement.
Experience in managing multiple tasks and projects simultaneously.
