Quality R&D Site Specialist

Náplň práce, právomoci a zodpovednosti:
The role is responsible for providing Quality Assurance support across the Global Oral Health Scale Up Facility (GOHSU) and broader R&D quality activities at the Levice site. The successful candidate will contribute to the establishment, qualification and ongoing quality oversight of the facility while ensuring compliance with GMP requirements, applicable regulations and Haleon Quality Standards. Working within a small and agile quality team, you will support a broad range of quality activities across the product lifecycle, including audits, quality documentation, deviation investigations, change controls, equipment qualification and validation. This role requires a broad end-to-end understanding of Quality Assurance and close collaboration with cross-functional teams to support the successful scale-up and commercialization of innovative Oral Health products.

Key Responsibilities:
• Guide and approve qualification and validation activities for systems, equipment and facilities, ensuring readiness for manufacturing and testing activities.
• Provide Quality Assurance oversight and support for Change Controls, Deviations, Laboratory Investigations and other Quality Management System processes.
• Review and approve quality documentation including GMP procedures, protocols, reports and records to ensure compliance with regulatory and Haleon Quality Standards.
• Perform final QA release activities for materials and products, as applicable.
• Provide QA support for third-party management activities and quality-related supplier interactions.
• Review and approve documentation related to method transfers, cleaning validation, equipment qualification and other GMP activities.
• Support and participate in internal and external audits and inspections, ensuring inspection readiness and effective follow-up of findings.
• Contribute to the development, review and implementation of local and global SOPs related to R&D manufacturing and quality activities.
• Collaborate with cross-functional teams to support facility qualification, product scale-up, technology transfer and commercialization activities.
• Ensure that regulatory requirements and Haleon Quality Standards are consistently implemented, maintained and continuously improved across GOHSU operations.

What makes this opportunity different?
Join a small and agile quality team where you will gain exposure across a broad range of Quality Assurance activities rather than a single specialist area. You will work with innovative technologies and play a key role in bringing new Oral Health products from development to market. The role offers the opportunity to influence quality processes, contribute to continuous improvement initiatives and build experience across the full product lifecycle within a global consumer healthcare company. The role also offers opportunities for professional growth within Quality, R&D and global quality organizations.

Požiadavky na zamestnanca:
• Minimum 3-5 years' experience in Quality Assurance, Technical Operations, Quality Control or Product Development within a regulated manufacturing environment, preferably in the pharmaceutical, consumer healthcare, cosmetic or food industry. Broad understanding of Quality Assurance principles, with the ability to work across multiple quality disciplines and support quality activities throughout the product lifecycle.
• Good knowledge of quality management systems and regulatory requirements (e.g., GMP, ISO 13485).
• Experience with regulatory requirements related to the production of oral care products, medical devices or medicinal products.
• Experience with equipment qualification, validation activities, change controls, deviations and laboratory investigations.
• Experience supporting manufacturing or quality control operations within a GMP-regulated environment.
• Experience with internal and external audits and inspections.
• Ability to prepare, review and approve technical and quality documentation.
• Experience working in international and cross-functional environments.
• IT systems literate (MS Word, Excel, PowerPoint) and familiar with electronic Quality Management Systems (e.g., Veeva QMS).
• Fluency in both English and Slovak, with the ability to communicate effectively in technical and business environments.