QC Compliance Specialist

Sanofi; Munster; In loco; EUR 42.000 - 56.000; Tempo pieno

Vantaggi offerti da questo lavoro

Onsite gym

Medical Centre

Competitive benefits

Descrizione del lavoro

Sanofi Waterford is seeking a QC Compliance Specialist to join our on-site team in Waterford, Ireland. The role focuses on quality control processes, regulatory compliance, and active involvement in audits and inspections to ensure cGMP adherence.

You will represent QC within the QMS, drive investigations, CAPAs, change controls, and continuous improvement initiatives while supporting regulatory inspections and maintaining local QC documentation.

Competenze

• Third Level qualification (degree in science or related discipline preferred).
• Experience in quality control within pharmaceutical industry and GMP/regulatory knowledge.
• Experience managing internal audits and external regulatory inspections.
• Understanding of pharmaceutical regulations, guidelines and standards (FDA/EMA/ICH).
• Ability to analyze compliance issues and develop effective solutions.
• Strong verbal and written communication to convey compliance requirements.

Mansioni

• Representing QC for processes led by QMS team at site level.
• Investigating quality control events and discrepancies; implementing CAPAs.
• Managing follow-up and progress tracking of events, change control and CAPAs.
• Contributing to develop, implement, and maintain an effective QC compliance program.
• Issuance and approval of local QC documentation aligned with site QMS.
• Investigating timely quality events and implementing remediation actions.
• Providing support during regulatory inspections and audits.
• Leading continuous improvement initiatives in QC with QC excellence team.
• Ensuring compliance to cGMP at all times.

Conoscenze

Quality control

GMP knowledge

Regulatory compliance

Audits & inspections

Root cause analysis

Stakeholder communication

Formazione

Science degree

Descrizione del lavoro

• Working Arrangements: On-site, days role

Job title:

QC Compliance Specialist

• Location: Waterford, Ireland
• Job Type: Fixed Term Contract/12months
• Working Arrangements: On-site, days role

About The Job

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

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.

Key Responsibilities

The QC Compliance Specialist has a primary role in:

• Representing QC for the processes led by QMS team at site level
• Investigating in a timely manner and resolving any quality control events, issues, or discrepancies from his/her perimeter. Implementing remediation actions from findings and CAPAs
• Managing the consolidated follow-up and Progress tracking of events (eg deviation, lab investigations), change control and CAPAs, related to QC, coordinating with respective QC areas and other involved functions, to ensure they are managed and closed as committed
• Contributing to develop, implement, and maintain an effective compliance program for QC
• Ensuring issuance and approval of appropriate local quality control documentation, when required to support the QMS processes applicable to QC, in alignment with the site QMS
• Investigating on a timely manner and resolving any quality control events, issues or discrepancies from his/her perimeter. Implementing remediation actions from findings and CAPAs
• Providing support during regulatory inspections and audits
• Leading initiatives for continuous improvement in QC, in coordination with QC excellence team
• Ensure compliance to Good Manufacturing Practices (cGMP) at all times

About You

To excel in this role you will need to have:

• Third Level qualification (degree in science or related discipline preferred)
• Experience in quality control within the pharmaceutical industry, including knowledge of Good Manufacturing Practices (GMP) and regulatory requirements
• Experience in managing internal audits and external regulatory inspections, including preparation, execution, and follow-up
• In-depth understanding of pharmaceutical regulations, guidelines, and standards (e.g., FDA, EMA, ICH)
• Ability to analyze complex compliance issues, identify root causes, and develop effective solutions
• Proficiency in identifying issues and implementing effective solutions to resolve quality control problems
• Strong verbal and written communication skills to effectively convey compliance requirements and updates to various stakeholders

Pursue Progress. Discover Extraordinary.

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.