Regulatory Systems Associate

3 weeks ago

Kingston upon Hull, United Kingdom Reckitt Full time

Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose.

Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege.

**Research & Development**:
**About the role**:

- Want to raise the bar? As a Regulatory Systems Associate at Reckitt, you’ll have the freedom to make certain that our new products are all of the highest quality.**Regulatory Systems Associate**

**Kingston upon Hull, East Yorkshire**

**Competitive Salary & excellent benefits package including annual performance bonus, 10% pension contribution, private healthcare, hybrid working, ShareSave scheme and much more**

**Hiring Manager: Mike Dazzo (Systems & Process Senior Manager)**
- You'll ensure that Regulatory systems are fit for purpose, ensure that the user community is supported and fully trained in the functionality of the systems and management functions are provided with appropriate metrics to enable RB business to maintain compliance of our products with regulations**Your responsibilities**:

- Perform system administration and user administration activities
- Ensure maintenance of business based activities (system & Processes) are aligned to the QMS to ensure ongoing compliance and validation
- Ensure validation and change control is carried out correctly, particularly to satisfy regulatory & Reckitt requirements
- 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
- Work with Project teams to ensure system changes are appropriately transitioned to BAU status
- Lead with system updates and ensure these are implemented according to Change Control methodology
- Provide timely key quality performance indicators and insightful reports for the system and processes within the system
- 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
- Establish and maintain an active user community of “Super Users” that can provide local expert support to the end user base
- Host regular forums with the SU’s to impart updates and to take feedback to improve utilisation of the system
- Ensure the SU community have the right tools/resources to carry out their duties
- Ensure users working on GxP system (s) are trained to the appropriate level for the processes within QMS and CSV.
- Provide support to the Project team during system updates and development activities
- Maintain a good understanding of the system activities, configuration and parameter setup
- Support the development and delivery of system & process specific SOPs and any other key system maintenance documentation
- Support the Project team with assessing the impact of proposed system changes
- 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.
- Support periodic reviews of the system and ensure all actions from the review are managed and completed on time
- Present evidence of compliance to Regulatory Inspectors for areas of own responsibilities if required.

**The experience we're looking for**:

- 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.
- Strong IT literacy is important for role
- Experience with business process and requirements analysis as a critical input to systems design and validation.
- Strong Computer System Validation (CSV) and Good Practices (GxP)
- Experience with Data Transformation and Analytics is desirable but not required.
- Understanding of regulatory requirements relevant to the RB portfolio of products and electronic systems (GAMP)
- Influencing skills in areas with no direct reporting authority
- Commercial awareness and understanding of corporate codes of conduct
- Strong interpersonal and communication skills
- Experience working in a global / multi-site, matrix environment
- Excellent listening, interpersonal, written and verbal communication and presentation skills
- Flexibility in thinking, with creative and pragmatic problem solving skills.
- Ability to effectively prioritise and execute tasks while under pressure

**The skills for success**:

- Regulatory experience / knowledge
- Project Management
- Data Transformation & Analytics
- Commercial Awareness

**What we offer**:
With inclusion at the heart

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