Regulatory Systems Associate - REACH
Reckitt Benckiser
- Kingston upon Hull
- Permanent
- Full-time
- Ensure maintenance of business-based activities are aligned to the Reckitt QMS to ensure ongoing compliance and validation
- Provide support to business users and outsourcers such as but not limited to training, troubleshooting and resolving issues
- Ensure necessary measures in place to maintain data integrity and monitor system performance, security and access.
- Ensure that all documentation relating to processes within the eQMS are created and maintained to relevant levels of Good Documentation Practice and internal documentation standards.
- Provide Insights to management to enable them to drive the right behaviours regarding the utilisation of the system
- Provide support to all users of Regulatory systems in a consultative capacity to continually improve quality and compliance; such as but not limited to training, troubleshooting and resolving issues
- Provide support to the Project team during system updates and development activities
- Work with the business system owners & IT teams to support audits (internal & external) across the product lifecycle to confirm compliance of the system with local, regional and industry standards.
- Experience of working in the Healthcare, Personal Care, Medical Device or other Healthcare related industry is desirable.
- Chemicals/Medicines Regulations and Compliance Expertise (REACH, XEVMPD, UDI) is desirable.
- Understanding of manufacturing processes with a focus on understanding Bills of Material (BOM) and the processes by which a breakdown of constituent substances are determined for products manufactured
- Experience with business process and requirements analysis as a critical input
- Strong Computer System Validation (CSV) and Good Practices (GxP)
- Experience with Data Transformation and Analytics is desirable
- Understanding of regulatory requirements relevant to products and electronic systems (GAMP).
- Influencing skills in areas with no direct reporting authority
- Excellent written and verbal communication and presentation skills
- Flexibility in thinking, with creative and pragmatic problem solving skills.