Website Thermo Fisher Scientific
This listing is about Thermo Fisher Scientific in Warrington, England, United Kingdom
About the job
Business Job Title: Validation & Quality Specialist –Full Time
Job Profile Title: Quality Specialist
Direct Report To: Quality Manager
Group/ Division: Life Sciences Solutions/GSD
Career Track: Professional
Position Location: Warrington
Number of Direct Reports: 0
When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
Mentors the business specifically in developing validation strategies for new and existing manufacturing processes i.e. vision systems/packaging processes/pick and place systems.
Provides support with computerised systems validations e.g. spreadsheet & bespoke software packages (ensuring vendors deliver quality information to allow systems to be validated efficiently & successfully).
Expected to take initiative and drive change across the business in order to promote both compliance, product quality improvements and efficiency by ensuring that the validation process adds value and challenges current and new manufacturing processes and systems to ensure product quality is assured.
Assists with QMS processes ensuring compliance with ISO13485/ISO18385/Global and Corporate Policies – seeking continuous improvement in all aspects of the QMS.
Works with Operations, R&D and QA team focusing on improvement projects to improve product quality.
This position takes responsibility in supporting the business with preparation of validation protocols for new and existing equipment i.e. to create standard approaches in development of user requirement specifications & IQ/OQ/PQ plans for clean rooms/electro-mechanical systems/bespoke software & any automated manufacturing process.
This position will improve and thus maintain the site validation master plan (VMP) by developing the business strategy and ensuring key manufacturing processes and automated systems have been validated to a robust qualification plan.
This position will develop techniques for spreadsheet validation – mentoring the business to create value in the validation process ensuring efficiency & standard approaches in all depts.
This position will be able to take part in/facilitate risk assessments (PFMEA/DFMEA) to assist in improving both product and processes. This position will also be a QA lead on CAPA projects (ensuring product/process improvements are executed in a timely manner).
This position will support the change control process ensuring compliance with ISO/Corporate guidelines and championing process improvements.
This position closely interacts and builds effective relationships with people across site to promote
Quality, consistency and compliance thus providing quality support to manufacturing and NPI projects. This position demonstrates courage and willingness to determine appropriate action and make risk-based timely decisions to support the customer, operations and compliance with a focus on validation strategies within the manufacturing areas.
This position Identifies and drives improvement opportunities through effective communication and ensures where quality issues arise that root cause is determined and the appropriate actions are agreed and implemented and linked back to validation strategies where applicable.
- Degree in a scientific discipline or equivalent experience in a relevant discipline.
- Knowledge of ISO13485 or equivalent standards.
- Experience of authoring IQ/OQ/PQ documents.
- Knowledge of spreadsheet validation and GAMP 5 an advantage.
- Experience of ISO14971 (FMEA/PFMEA).
- Experience with Quality Improvement Tools (5 Why/pareto analysis/Run Charts).
- Experience of CAPA processes & problem solving within Process/Product Improvement multi-functional teams
- Ability to work on multiple tasks at any one time.
- Excellent communication and report writing skills.
- Experience of office packages and general computer skills. Ability to challenge existing approaches to compliance in order to seek improved ways of working.
- Ability to coach and influence others is essential.
- Travel requirements – some travel maybe required – 10% max
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
Company: Thermo Fisher Scientific
Job Location: Warrington, England, United Kingdom
Application Deadline: N/A
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