Quality Assurance Officer
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Trainee Qualified Person
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Hyper Recruitment Solutions are currently looking for a Device Quality Systems Officer to join a leading Pharmaceutical company based in the Cambridgeshire area. As the Device Quality Systems Officer you will be responsible for maintaining compliance through leading the change management process and maintaining a Design History File (DHF).
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Device Quality Systems Officer will be varied however the key duties and responsibilities are as follows:
1. Take responsibility for the change management process, ensuring all raised change requests are logged and assessed to ensure the completion of deliverables, this will include supporting the assessment of change requests to device design documents or production and assembly processes.
2. Ensure appropriate quality processes and records are set up and maintained in all suppliers and out-sourced activity providers to ensure compliance with company procedures, GMP's and required device guidelines.
3. Support Quality Systems and processes to ensure they are effective efficient and meet business needs, this includes managing deviations and non conformances from third parties, ensuring that CAPA's are effectively implemented.
4. You will assist in trend analysis and the risk assessment process, ensuring that long term supply remains compliant with the Design History File requirements through the life cycle of the products. This will involve effective communication between internal and external departments/parties.
To be successful in your application to this exciting opportunity as the Device Quality Systems Officer we are looking to identify the following on your profile and past history:
1. Prior experience working in a Quality/Compliance related position ensuring GMP standards are maintained.
2. A working knowledge and practical experience with ISO14971 and a compliant QMS (ISO13485/ISO9001).
Key Words: GMP | GXP | Design History File | Medical Devices | ISO14971 | ISO9001 | ISO13485 | Compliance | QA | Quality Assurance | Device Quality | QMS | Quality Systems | CAPA | Non Conformances | Audit | Deviations | Suppliers | Third Parties | Device Design Documents | Modifications | Life Cycle
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.