We are seeking a Supplier Quality Specialist for a permanent opportunity with a pharmaceutical company based in Clonmel, Co. Tipperary.
The role will provide quality oversight, support and expertise across site quality systems, ensuring alignment with business priorities, including compliance, supply, strategy and profitability.
The team operates collaboratively, with an emphasis on coaching and facilitation to support the success of the site. The Quality Specialist will be accountable for quality systems within the site and will contribute to the delivery of a robust Quality Management System (QMS) that supports a flexible, collaborative and multi-skilled working environment.
The successful candidate will demonstrate the ability to develop and improve quality systems as an active member of cross-functional teams. They will support process improvement, model the organisation's leadership behaviours and apply MPS principles to promote continuous improvement and build a high-performance organisation.
The role also requires participation in and compliance with the organisation's Quality Management System requirements, including ownership of relevant quality processes.
Key Responsibilities and Duties
- Provide the site with knowledge and experience in Quality Systems.
- Apply quality systems knowledge to improve processes, solve problems, drive continuous improvement and execute tasks effectively.
- Contribute quality and compliance expertise to project teams and lead small projects.
- Coach and guide colleagues across the site.
- Understand and apply relevant regulatory and compliance requirements, remaining up to date with upcoming regulatory changes.
- Respond to non-standard requests arising from customer requirements.
- Make decisions within established guidelines and policies, prioritising work and allocating time effectively to meet deadlines.
- Support Corporate Quality in ensuring that site-level Quality Systems actions are implemented and completed.
- Participate in site inspections conducted by divisional teams, regulatory bodies and third parties, including follow-up actions where required.
- Participate in and lead internal inspections.
- Participate in Good Manufacturing Practice (GMP) walkthroughs.
- Manage supplier agreements and supply maps.
- Manage customer and service-level agreements.
- Support deviation management and approve change controls.
- Ensure the supply of high-quality products through the implementation and oversight of the site's Quality Management System.
- Champion the highest standards of quality and compliance across the site.
- Ensure the highest safety standards are maintained.
Skills, Training and Experience
- Strong Quality Assurance subject matter expertise gained through operational experience and education.
- Knowledge and experience in interpreting current regulatory requirements and providing independent quality support to the site.
- Demonstrated ability to work independently and deliver improvement initiatives with a moderate level of guidance.
- Proven ability to work effectively within teams and lead small project teams.
- Demonstrated ability to drive tasks through to completion.
- Proven track record of providing independent Quality support within a site environment.
- Advanced PC skills, including Microsoft Excel, Word and PowerPoint.
- Strong stakeholder management skills, with the ability to work with multiple decision-makers, auditors and cross-functional teams.
- Ability to build, maintain and strengthen trusted working relationships at all levels of the organisation.
- Strong decision-making skills, with the ability to take full accountability and responsibility.
- Energetic, proactive and positive approach to work.
- Demonstrated coaching and mentoring skills.