Qualified Person

Qualified Person (QP)

• Location: Waterford
• Job type: Fixed Term

About 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 work 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.

About the job

Our Team:

The Quality Assurance team is made up of QP's, Managers, Technical Leads, Team Leads and Quality Specialists, all of whom are dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options to millions of people globally. Being part of this team will allow you to work in a state-of-the-art sterile syringe filling facility. We produce both commercial and clinical products, with a very robust pipeline. It is because of this we are looking for more quality professionals to join our expanding team.

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. Your job, as Qualified Person (QP) will be to:

Main responsibilities:

The Qualified Person is responsible to ensure that licensed product is certified and released to market by a Qualified Person named on the commercial manufacturing license in accordance with EU directive 2001/83/EC, 2004/94/EC and in accordance with the requirements of Annex 16.

• Manage the batch disposition process to ensure timely release of product
• Ensure the batch disposition process maintains compliance with site practices & regulatory requirements
• Support major investigations, ensuring all product deviations are closed prior to batch release
• Participate in cross functional teams as Quality/Qualified Person representative
• Provide additional QP support to quality related issues, as the need arises
• Participate on internal committees/teams, as required
• Provide advice and direction to other departments on quality issues
• Ensure independence of the QP on decisions on quality related matters
• Build partnerships across the business to create a culture that demonstrates excellence in quality, compliance and continuous improvements
• Provide audit support as required for internal auditing program and supplier audits

About you

• cGMP experience with relevant work experience acting as Qualified Person, named on the Manufacturer's/Importer's Authorisation (MIA) ; consideration will be given to other relevant experience and education
• Post Graduate Qualification required (MSc or equivalent)
• Biologics manufacturing experience highly desirable
• Experience in Sterile Manufacturing and / or Clinical Trials Regulations highly desirable
• Problem solving, risk assessment and impact analysis abilities

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
• Play an instrumental part in creating best practice within our manufacturing facility
• Our Waterford site is easily accessible from the M9 and offers excellent facilities including a subsidized restaurant and newly refurbished gym

Pursue progress. Discover extraordinary.

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.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

#LI-EUR

Client-provided location(s): Athlone, Ireland

Job ID: Sanofi-https://jobs.sanofi.com/en/job/waterford/qualified-person/2649/15555691328

Employment Type: OTHER

Posted: 2024-08-02T12:39:35