Quality Assurance Specialist

Reference No. R2769394 ​

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.

As a member of the Quality Operations, Operational Quality team in B90, provide compliance support to Deputy Directors for the licensed product, teams in managing their day-to-day operations in compliance with Sanofi Pasteur quality systems requirements and Good Manufacturing Practices.

The incumbent will provide Operational Quality support to Deputy Directors for designated departments of Industrial Operations (such as: Bulk Manufacturing, Formulations Filling & Packaging, Media Services, Manufacturing, Quality Control, Global Engineering Maintenance, Materials Management/Logistics, Purchasing and Customer Service/Marketing, Manufacturing Technology, QOSA).

The incumbent is expected to work independently on Afternoon Shift as a Quality Assurance Specialist with a level of autonomy and authority for decision making as a delegate to the Deputy Director as necessary to drive process improvements, ensure ongoing compliance to requirements in the dossier, current GMPs, and also achieve process efficiencies.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main Responsibilities:

• Support the Operational Quality Deputy Directors in ensuring timely review, follow-up on closure and approval of various documents, such as: master batch records, operational log books, SOPs, SWIs, deviations, protocols, reports, work orders, that are within the scope or delegated.

• Ensure failure investigations/deviations are processed and that problem resolution occur prior to commitment date within Phenix. Ensure that batch recommendations are based on sound science and supporting reports are of high quality.

• Perform the role of QO Representative in coordinating, investigating and assessing Change Control Requests (CCR’s) and CAPAa as designated within this process. This activity will require the incumbent to determine if a change request impacts product and processes.

• In addition, the incumbent might have to be a QO Representative at various internal and external committees and board related to the management of the organization, such as: Sanofi Pasteur Change Control Board, Material Review Board, +QDCI (mandatory), FFast, etc.

• Ensure through shop floor presence and knowledge transfer, that there is in-depth GMP understanding as it pertains to specific operations and that issues are identified locally and dealt with through close collaborative contact with the various departments.

• In conjunction with the QO Quality System Internal Auditor and Vendor Auditor, perform audits and support functions performing GMP activities to ensure compliance with cGMP standards, site and corporate policies.

• Make assessment decisions and authorization for processing / reworking, manufacturing at risk.

• Project team participation.

About You

Key Requirements:

• Bachelor of Science degree specializing in Microbiology, Biochemistry, Immunology or Pharmacology with 5+ years of relevant experience in Quality Operations from a Pharmaceutical or Biologics Manufacturing facility required.

• Master of Science degree in Microbiology, Biochemistry or Immunology with 3+ years of relevant experience in Quality Operations from a Pharmaceutical or Biologics Manufacturing facility.

• Act for Change, Cooperate Transversally, Strive for Results, Thinking Strategically.

• Strong decision-making skills.

• Excellent communication and influencing skills.

• Good understanding of GxPs, regulatory and compliance trends.

• Problem solving skills.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs

Sanofi is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives. We welcome and encourage applications from all qualified applicants.  Accommodations for persons with disabilities required during the recruitment process are available upon request.

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