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Product Quality Specialist

2 weeks ago

Folkestone, United Kingdom BioTalent Full time

**The Role**

Lead effective management of change within the Europe organization, utilizing 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.
- 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 Europe sites for corporate initiatives and assumes the role of Quality Expert:

- Shares the vision, challenges and needs of 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.

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.

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

**Skills & Knowledge**
- 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 ideas across a range of groups
- Previous experience working within and leading cross-departmental teams in projects or initiatives
- Excellent interpersonal skills, being a team player and attention to detail

**Job Types**: Full-time, Permanent

**Salary**: Up to £39,000.00 per year

**Benefits**:

- Company pension
- Flexitime
- Work from home

Schedule:

- Flexitime
- Monday to Friday

Supplemental pay types:

- Bonus scheme

Ability to commute/relocate:

- Folkestone: reliably commute or be willing to relocate with an employer-provided relocation package (required)

Work Location: Hybrid remote in Folkestone