QA Specialist

• Location: Waterford

About the job

At Sanofi, we’re committed to providing the next-gen healthcare that patients and customers need.

Reporting directly to the Quality Assurance Team Leader, as a critical leader for Sanofi, you will play an integral role within the Sterile Operations area, transforming the support provided to these functions.

Shift Role 24/7 pattern

For more than 20 years, our Waterford team has continued to grow and diversify to serve patients around the world. Today, a team of almost 800 works together at a state-of-the-art biopharmaceutical and medical device campus. Recognized through multiple local and national awards, Sanofi Waterford offers flexible working and access to a world of opportunities to grow your career at one location. As well as attractive benefits, the team enjoy access to an onsite gym and medical Centre that underpin a strong commitment to health and wellbeing.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main responsibilities

We are a highly motivated and committed Team of Quality Assurance specialists conducting a wide portfolio of highly specialised activities to support 24/7 Lyophilisation Operations in Sanofi Waterford. Our team works in a fast-paced organisation delivering solutions for our patients and customer needs.

• Acts as Quality support for systems / processes providing guidance / feedback on quality issues related to Sterile Manufacturing activities
• QA Specialist to focus on Batch release execution
• Assist in achieving timely and compliant final product disposition
• Review, approve, and support procedures and production/testing records as required
• Ensure compliance with aseptic techniques and sterile manufacturing regulations
• Perform timely review of documentation / investigations / reports highlighting and assisting in the resolution of concerns commensurate with risk
• Collaborate with cross-functional teams to support quality initiatives and continuous improvement efforts
• Work with relevant departments to ensure timely closure of quality actions / findings
• Conduct duties in a safe manner and report all safety issues or concerns
• Maintain work area to good housekeeping standards
• Support team in achieving team goals/targets
• Attend team meetings as required
• Measure and report RFT / trend data and work with departments to resolve recurring issues
• Participate in internal supplier and regulatory audits and key quality initiatives as appropriate
• Perform critical/ constructive review of procedures and practices
• Support deviation investigations ensuring deviations are closed prior to product release
• Ensure compliance to Good Manufacturing Practices (cGMP) at all times

About you

To excel in this role, you will need to have:

• Minimum of 5 years previous experience in sterile manufacturing operations is preferable; in particular strong understanding in the management, manufacture and release of sterile product
• Proven ability to provide quality expertise and support to the QA team and site teams
• Proven ability to support the delivery of tasks in a highly regulated manufacturing environment
• Effective technical knowledge of sterile manufacturing processes
• Strong knowledge of QA methodologies, tools, and processes
• Experience with quality oversight in manufacturing operations
• Excellent analytical, problem-solving, and decision-making skills
• Strong attention to detail and ability to work in a fast-paced environment
• Experience with regulatory inspections and audits is a plus
• Effective technical knowledge of sterile manufacturing processes
• Operational experience of quality systems in a dynamic manufacturing environment
• Knowledge of requirements for cGMP, US and EU regulatory requirements
• Full understanding of relevant quality and compliance regulations
• Effective facilitator
• Good communication skills at organisation, team and individual levels
• Understands KPI’s for the team and site
  • Excellent interpersonal skills
  • Excellent influencing skills
  • Excellent presentation skills
  • Flexible approach – comfortable with on-going change
  • Takes personable responsibility for their actions
  • Good communicator who is comfortable to work as part of a team
  • Focused on achieving results
  • Self-starter and able to work under minimum supervision 
  • Excellent accuracy
  • Strong attention to detail 
  • Working knowledge of computer packages

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 and at least 14 weeks’ gender-neutral parental leave

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