We are proud to have been partnering a global manufacturing client for some 16 years + and we are supporting with an exceptional new permanent opportunity for a:
Change Control and Quality Management Specialist.

This is a company that genuinely cares about their people, their products, their consumers and the environment and is a place where you can make a difference, in an exceptionally supportive environment.

The Change Control & Quality Management Specialist (CCQMS) will lead effective management of change within our clients Europe organisation, utilizing change control methodologies to implement local, regional and global quality change initiatives, maintaining their European operations in a state of compliance with GMPs and applicable regulations.

Package:
Attractive salary depending on experience
Company performance related annual bonus at 4%
Impressive 9% matched pension contribution scheme
Health Cash Plan
Life Assurance at 4 x base salary
24 days holiday plus you can buy/sell 3 days per year, plus bank holidays
Monday to Thursday 9am – 5pm with an early finish on Friday!
Permanent on site position

Skills & Knowledge & Experience we are seeking:
Applicants will require extensive experience working in Quality Assurance within the Cosmetic or Medical Devices industry with broad experience of all key areas of Quality Assurance.
Working Knowledge of the MDD, MDR, 21 CFR 820, ISO 13485, ISO 14971, ISO 22716.
Previous experience in delivering training to all levels of the business to improve compliance and foster support for the QMS
Experience representing organisations at audit / inspection
Experience of data analysis, data trending and preparing KPI’s.
Technical knowledge of consumer products, medical devices, and/or pharmaceuticals.
Experience of successfully leading effective change implementations at site level
Experience in data analysis and review (including trend analysis) for communication to management teams
Excellent ability in communicating complex ideas across a range of groups
Excellent interpersonal skills, being a team player and attention to detail

Education and Experience
University degree in a related field of Science or Engineering
Professional typically with over 3 years of technical experience and a demonstrated track record

The Position:
Ensuring documents, files and actions are being properly maintained and controlled
You will 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 and 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 non-conformances
Responsible for the management and oversight of the change control (CC) program; evaluates the CCs, their impacts and the identified actions, whilst ensuring 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.
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 program
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
Collation of Metrics and Scorecards
Deviation Process Management
Maintains strong links with Regulatory personnel with regards applicable to new or changes in regulations, GMP, ISO standards
Establish a strong quality mindset within the organization to analyse and resolve product quality issues.
This role carries responsibility to comply with and promote compliance with the relevant GMP and hygiene procedures and standards in the activities they undertake within the facilities.

If you have the required background, knowledge and experience for this position and would like to be considered, the please apply with an up to date CV and you will be contacted as swiftly as possible.


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