Change Control and Quality Specialist

3 weeks ago


Folkestone, United Kingdom Church & Dwight Full time

A collective energy and ambition. A place where you can make a real difference.

We’re a company that genuinely cares about our people, our products, our consumers and the environment.

Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership. We have a shared passion to work hard, innovate and push boundaries.

United by the belief that when we strive for growth, anything is possible. While we might not be the largest company in our industry, we believe we can have the biggest impact because: Together We Have the Power to Win.

Do you have experience of leading change within a multinational fast-moving consumer goods or pharma organisation? Have you worked closely with a range of cross-functional stakeholders? Do you have a working knowledge of ISO 22716 and ISO 13584?

If the answer is yes - then look no further as Church & Dwight UK Ltd have an exciting opportunity for a permanent Change Control and Quality Specialist based at our manufacturing site in Folkestone, Kent.

The Change Control and Quality Specialist is responsible for leading the effective management of change within the C&D Europe organisation, utilising change control and project management methodologies to implement local, regional and global quality change initiatives, continuous improvement projects, the launch of imported products, and coordination of special projects, including local and corporate initiatives

Day to day responsibilities for the Change Control and Project Specialist:
- Responsible for ensuring documents, files and actions are being properly administered- Perform historical searches to support risk assessments, NC/CAPA investigations, and Validations.- Support the development, implementation, and continuous improvement of the QMS- Provide support to NC owners on performing proper non-conformance documentation.- Use critical reasoning skills to participate in, conduct, and review investigations into quality issues.- Ensure implementation of adequate controls and corrective actions to prevent the recurrence of nonconformances- Responsible for the management and oversight of the change control (CC) program; evaluates the CCs, their impacts and the identified actions. Assure actions do not conflict with existing procedures, GMPs or applicable regulations.- Ensures the relevant stakeholders are aware, included and / or consulted when scoping a CC to obtain appropriate management support- Compiles data and generates the KPIs related to the change requests.- Contribute to Quality System processes. This may include eDMS, training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, and validation.- Identifies opportunities for improvement for the CC programme- Carries out the necessary follow-ups for the completion of the related actions according to the deadlines allocated. Gathers evidence related to actions.- Provides or co-ordinates training to support the execution of the change control system, acts to provide coaching and guidance to CC owners- Evaluates and identifies Quality needs for all projects. Takes strategic approaches to minimize project costs and delays in realization.- Acts as ambassador of the Church & Dwight Europe sites for corporate initiatives and assumes the role of Quality Expert:
- Shares the vision, challenges and needs of C & D Europe based on mandatory requirements;-
- Collects the comments and questions of the experts affected by the project and communicates them to the project team;-
- Accompanies the users during the project deployment, is the SME and “go to person”.-
- Utilises digital tools to support the completion of projects where relevant- Acts as the point of contact for local and global new product projects to ensure Quality oversight is maintained throughout the project- Work closely with Global Quality Assurance teams to identify and implement improvement programs.- Establish a strong quality mindset within the organization to analyze and resolve product quality issues.- University degree in a related field- Significant technical experience and a demonstrated track record- Extensive experience working in Quality Assurance within the Cosmetic or Medical Devices industry.- Broad experience of all key areas of Quality Assurance.- Working Knowledge of the MDD, MDR, 21 CFR 820, ISO 13485, ISO 14971, ISO 22716.- Experience of successfully leading effective change implementations at site level- Proven capability in leading quality projects and continuous improvement.- Prior experience in deploying project management tools and techniques- Qualification within a recognised project management discipline is desired but not essential- Experience in data analysis and review (including trend analysis) for communication to management teams- Excellent ability in communicating complex id



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