Position: Material Release, Specialist II
Hiring Manager: Manager, QC Raw Material & Lab Service
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 Evolutive Facilities to our global industrial footprint. These production units (EVF) 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 Evolutive Facilities (EVF) will enable more responsive and flexible manufacturing across multiple vaccine and biological platforms including mRNA, while minimize our impact to the environment. Our EVFs will help improve people’s lives by giving them faster access to more treatments.
In this context, we are looking for one Material Release Specialist to participate in the setting up of the material release process for our new site based in Singapore.
Main responsibilities:
Own, author and perform periodic review of incoming material (e.g. starting materials, chemical raw materials, single-use technologies, production consumables) specifications.
Collaborate with technical teams such as MSAT, QC and Supplier Quality to ensure that incoming material specifications are scientifically sound and in line with regulations.
Initiate and own Change Control records to drive and perform revisions to material specifications, as required.
Implement and maintain the site release program for incoming materials, and the continuous improvement of the program.
Be the Subject Matter Expert on release of incoming materials to handle all queries during regulatory and customer audits / inspections.
Independently review incoming material related documents or records (e.g. supplier certificates, incoming material receipt records, deviations, CAPAs, laboratory investigations and change controls), ensuring these meet the regulatory requirements.
Perform timely release of incoming materials, ensuring all quality aspects of the lots are reviewed and assessed.
Initiate deviations related to incoming materials when required and perform escalation to the necessary stakeholders, as required.
Support deviation investigations related to incoming materials in collaboration with other stakeholders (e.g. QC, Supply Chain and Quality Assurance).
Education and Experience
Bachelor’s or Master’s Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology or related life Sciences or Technology with at least 7-8 years of experience in related pharmaceutical industry.
Key technical competencies and soft skills:
Good understanding of regulations and standards of the pharmaceutical industry, global quality policies and data integrity requirements.
Strong knowledge of the quality systems and material release process.
Excellent verbal and written communication skills; effective communication and presentation skills.
Good understanding of risk-based decision framework.