Change Control and Quality Specialist

Job Description

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.

Are you experienced in change control from a Quality Assurance perspective? Have you led on the development and continuous improvement of a Quality Management System in a Medical Device or Cosmetic setting?

If the answer is yes - then look no further. Church & Dwight UK Ltd have an exciting opportunity for a Change Control and Quality Specialist to join our Quality Assurance team based in Folkestone, Kent, on a permanent basis.

This role is responsible for leading the effective management of change within Church & Dwight’s European organisation, utilising change control methodologies to implement local, regional and global quality change initiatives.

Key responsibilities include:

• Responsible for ensuring documents, files and actions are being properly maintained and controlled.

• Utilise legacy information through searches of historic data to support risk assessments, NC/CAPA investigations, and validations 

• Support the development, implementation, and continuous improvement of the QMS

• Support Quality investigations related to the QMS/Change control process

• Use critical reasoning skills to participate in, conduct, and review investigations into quality issues related to QMS and Change Control processes.

• 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

• Escalate issue identified within QMS or change control processes that require management support and immediate action.

• 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.

• 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

• Is responsible for the audit readiness program and maintains the “audit ready” status of facilities, personnel and processes. Includes but is not limited to: Inspection Site Readiness Manual, Floor Tours, Employee Preparation for Audits, etc.

• Manages the internal audit program and acts as coordinator for audits

• Issues recommendations in response to audit observations. Ensures that the proposed responses and corrective actions are appropriate to the situation.

• Manages the Annual Product Quality Review program (APQR). Uses statistical tools to identify potential issues and/or trends in operations and make recommendations for improving the quality of products and processes.

• Ensures the continuous maintenance of the performance and efficiency of the quality system

• Deviation Process Management

• Establish a strong quality mindset within the organization to analyze and resolve product quality issues.

The ideal candidate will have proven experience managing Change Control and a QMS within a comparable industry (such as Cosmetic or Medical Devices), in addition, they will:

• Hold a University Degree in Sciences, Engineering or a related relevant professional qualifications to degree level.

• Have extensive experience working in Quality Assurance within the Cosmetic or Medical Devices industry.

• Have broad experience of all key areas of Quality Assurance.

• Have a working Knowledge of the MDD, MDR, 21 CFR 820, ISO 13485, ISO 14971, ISO 22716.

• Have previous experience in delivering training to all levels of the business to improve compliance and foster support for the QMS

• Be experienced representing organisations at audit / inspection

• Have experience of data analysis, data trending and preparing KPI’s.

• Have technical knowledge of consumer products, medical devices, and/or pharmaceuticals.

• Be experienced in successfully leading effective change implementations at site level

• Have experience in data analysis and review (including trend analysis) for communication to management teams

• Have excellent communication skills, able to share complex ideas across a range of groups

• Have excellent interpersonal skills, being a team player and attention to detail

In return, we offer a competitive salary with 24 days annual leave, company performance related bonus, health cash plan, life assurance cover and highly competitive pension scheme.

For more information on our company, our brands and our culture visit us at http://www.churchdwight.co.uk/

When applying for a role and sending your cv, you understand that the Company will hold your personal data in relation to your prospective employment and will process that data for legitimate business reasons within the requirements of UK data protection laws currently in effect and as they become applicable, including the Data Protection Act 1998, the General Data Protection Regulation (Regulation (EU) 2016/679)) and any successor legislation. Candidate Privacy Notice.