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QC Compliance Specialist (Investigation Lead)

date posted 04/15/2024
contract type Full time
job id R2735453
location Waterford, Ireland

Location: Waterford

Job type: Fixed term, Full time

About the job

Our Team in Waterford:

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. Recognised 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.

Main responsibilities:

  • Driving of all Quality Metrics for the department
  • Forward review of Quality Metrics to ensure no over-dues
  • Procedure effectiveness and simplification and actively contribute to continuous improvement initiative
  • Ensure effective co-ordination and support for external and internal audits for the department.
  • Perform critical / constructive review of procedures and practices. Identify and lead projects to make step change improvements to the department’s Quality.
  • Conduct duties in a safe manner and report all safety issues or concerns
  • Support leadership team in achieving goals / tasks
  • Actively contribute to continuous improvement initiatives utilising lean methodologies where appropriate
  • Liaise with Quality Assurance Representative to support and improve RFT in the area and Always Audit Ready
  • Maintain training in critical test activities as required in the laboratory
  • Provide audit support to the QC team including performing routine and pre-audit walkthroughs, assist SMEs to prepare and coordination of QC requests during audits
  • Review and update QC procedures and processes to ensure compliance to current and updated requirements and regulations

About you

Experience:

  • Established background in related QC/QA roles
  • Experience of stability program management preferable

Soft skills:

  • Excellent communication and interpersonal skills
  • Ability to work effectively in cross-functional teams
  • Accuracy and attention to detail 

Technical skills:

  • Extensive knowledge of cGMP and GDP in a regulated environment 
  • Working knowledge of quality systems in a regulated environment 
  • Excellent technical writing skills
  • Continuous improvement techniques

Education:

  • Honours Degree in a relevant Science discipline

What we offer

  • Contract for 23 months
  • A generous package including flexible benefits, and are committed to helping you have a healthy work-life balance throughout your career with us
  • We have highly subsidised restaurant with free tea and coffee
  • A newly refurbished gym is available onsite for a small and highly competitive annual membership fee
  • You will be based in our Waterford site which is accessible from M9
  • Parking available onsite

If the description fits your experience and has aroused your interest, please apply so we can get in contact with you!

Discover our Code of Conduct, that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document, before applying.

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Pursue Progress, Discover Extraordinary

#LI-EUR

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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