Data Integrity and Quality Systems Specialist
vor 3 Wochen
About Haleon
Haleon is a leading consumer health company dedicated to enhancing everyday health for billions of individuals. Our focus is on advancing our renowned brands, blending profound human insight with trusted science to drive growth and innovation across our portfolio. We foster a unique culture that sets us apart, and we invite you to be part of this journey.
Opportunity to Shape the Future
This is an opportune moment to join us and play a pivotal role in shaping the future – an opportunity to contribute to something truly exceptional.
About the Role
The primary objective of this role includes:
- Acting as the primary liaison with the Global Quality Organization to ensure the effective implementation of the Haleon Quality System on-site.
- Owning the Risk Management Process to establish and uphold the risk identification, documentation, and escalation processes in alignment with global standards.
- Analyzing and presenting key performance indicators to the Site Quality Council promptly.
- Overseeing Change Control, Deviation, CAPA, and Laboratory Investigation processes to ensure compliance on-site, following HQS guidelines.
- Assessing Quality Alerts and ensuring timely implementation of associated Corrective and Preventive Actions (CAPAs).
- Reporting operational KPIs to the Site QA in Nyon and at corporate levels.
- Leading the implementation of the data integrity strategy to ensure regulatory compliance for data management across all GxP categories.
Key Responsibilities
1. Data Integrity Champion
- Lead Quality Management System (QMS) and regulatory compliance for data integrity, including monitoring at the site level.
- Assist in ensuring adherence to systems and documentation.
- Develop a Data Integrity Quality plan and communication strategy for event prevention and detection.
- Regular updates on data integrity elements, coordinating system evaluations and CAPAs.
- Provide audit support and share best practices.
2. Haleon Quality System Champion
- Ensure site compliance with HQS and communicate QMS information.
- Monitor HQS implementation and support inspection readiness.
- Participate in the HQS Community of Practice.
3. Risk Management Process Owner (RMPO)
- Ensure the deployment of the Risk Process at the site.
- Lead local risk escalation and provide RMS support.
- Act as the Risk Management Subject Matter Expert.
4. Quality Systems
- Provide KPIs, ensure process alignment, and oversee CAPA implementation.
- Coordinate the change control process and act as the contact for committee organization.
Qualifications and Skills
Essential requirements:
- Bachelor's degree or equivalent experience in Quality Science or Engineering.
- Minimum 7 years' experience in pharmaceutical industry QA or production.
- Thorough understanding of GMP regulations, Quality Systems, and manufacturing operations.
- Strong interpersonal and leadership skills.
- Focus on Safety, Quality, and Results.
- Proficient in GMP and regulatory requirements, including EU GMP and FDA CFR.
- Expertise in Quality Management Systems and Data Integrity management.
- Experience in the Pharmaceutical/Consumer Goods Manufacturing sector.
- Proficiency in both French and English.
- Effective communication skills.
- Ability to work collaboratively across organizations and influence key decision-makers.
- Exemplary in GxP, Health, Safety, and Environment standards, and company values.
Diversity, Equity, and Inclusion
Haleon is committed to creating a workplace where authenticity is embraced, and everyone can thrive. We value unique perspectives, encourage open dialogue, and ensure equitable outcomes for all. If you value flexibility in your work, we invite you to explore the possibilities within our agile working culture.
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