Location: Waterford- Onsite

Job type: 23-month FTC

“This is a day position with time initially on 24/7 shift”

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:

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.

Main responsibilities:

Indicate here the main job responsibilities with bullets points, avoiding Sanofi corporate jargon, acronyms, and gender-coded words (you can check if your language is neutral on this site)

Acts as Quality support for systems/processes providing guidance/feedback on quality issues

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

Experience:

Minimum of 5 years of experience working in a pharmaceutical or biotechnological organization

Minimum of 2 years leader experience working in a cGMP in a regulated environment

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.

Soft skills:

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

Technical skills:

Excellent accuracy

Strong attention to detail 

Working knowledge of computer packages

Education:

Third Level qualification (Bachelor’s degree in Life Sciences or related discipline preferred )

Languages:

Fluent English

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!

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, ability or gender identity.

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