Quality & Regulatory Specialist
Do you have a background working in QA/RA within a Medical Device or Pharmaceutical company?
We are looking for a Quality & Regulatory Specialist to join the Quality Department within a leading chemical manufacturer that develops chemical technology for the purification of air to preserve life and protect the environment? This is an excellent opportunity to join a busy this busy department.
The Quality & Regulatory Specialist will work closely with the Quality & Regulatory Manager to ensure the company readiness in compliance with standards and certifications.
* Assist in performing Post Market Surveillance.
* Member of internal auditor team.
* Interact with all areas of the business in order to process/co-ordinate:
- customer complaint investigations,
- identify incidents of non-conformance,
- support the company continual improvement and CAPA programme,
- approve and implement validation documentation
- product CE marking and US submissions
The Quality & Regulatory Specialist is an integral member of the quality team in achieving the quality objectives and initiatives for continuous improvement.
Responsibilities & Duties:
* Support the Quality & Regulatory Manager in the general maintenance of BQMS, regularly update the quality system performance and reporting data.
* Create, review and update relevant SOPs and Work Instructions needed to support/improve BQMS, Including ownership of the document and data control process.
* Facilitator of Corrective Actions and provide performance report on periodic basis.
* Provide support with CAPA, complaint and product investigation as needed.
* Provide training including generating training materials to attain necessary competence of personnel and/or increase their awareness of BQMS requirements.
* Maintain membership & subscriptions (e.g. BSI).
* Lead / support regulatory and customer audits ensuring timely closure to open actions advice / support on regulatory matters as required.
* To process customer complaints in accordance with company policy and procedure, assigning investigation/action to appropriate personnel and where necessary perform the investigation of the complaint.
* To review the outcome of the investigation for suitability and adequacy regarding resolution of the complaint and determining further investigation/follow-up where deemed appropriate.
* Ensure any samples received regarding the complaint are properly handled and stored.
* Identification of archive sample storage to allow timely sample retrieval in accordance with company procedure.
* Perform PMS activities to MDR requirements.
* Review and approve CE mark and FDA submissions.
* Develop and implement validation documents in an ISO controlled environment.
Knowledge & Experience:
* Experience in Validation protocols and reporting - Essential
* 2+ years' experience of CE Marking process and FDA submissions - Essential
* Significant experience in manufacturing environment or equivalent certification.
* Knowledge of international/harmonized standards, such as, ISO 9001/ISO 13485.
* Knowledge of QA principles and system concept.
* Experience in process control improvement projects.
Salary Range: £30,000 - £35,000 pa.
Location: Harlow, Essex
Sorry that we cannot contact all of you personally, but thanks in advance for your interest.
Please bear in mind that you may not hear from us straight away. Due to the high level of applications we receive every day, we can only respond to applicants whose skills and qualifications are suitable for this position.