CAPA and Complaints Specialist

Essex - Harlow
£30000 - £42000 Excellent Benefits
Job Reference

CAPA and ComplaintsSpecialist

Salary Guide: £30,000 - £42,000 pa

Harlow, Essex

* Do you have a background working in QA/QC within a Medical Device or Pharmaceutical company?

* Have you had exposure to ISO13485 & 21CFR820?

* Are you looking to develop your experience within CAPA?

* Are you interested in joining a leading chemical manufacturer that develops chemical technology for the purification of air to preserve life and protect the environment?

We are looking for a CAPA and Complaints Specialist to join the Quality Department. This is an excellent opportunity to join a busy department to:

* To oversee the site CAPA system, ensuring that investigation and root causing is performed to target time-lines/in conjunction with risk factor and that corrective actions are complete in line with due dates.
* To process customer complaints in accordance with company policy and procedure to drive towards accurate and satisfactory resolution.
* To interact with all areas of the business in order to co-ordinate customer complaint investigations and information gathering to identify incidents of non-conformance to support the company continual improvement and corrective action programme while maintaining an overall vigilance of compliance and the principles of current Good Manufacturing Practices (cGMP).
* Assist the Regulatory team in performing Post Market Surveillance.
* Member of internal auditor team.
* This job will be office based during regular business hours, although overtime may be required depending on the needs of the business

Responsibilities & Duties:

* 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.
* To liaise with the Quality Manager on issues of non-conformance or non-compliance resulting from a customer complaint, identifying the need for CAPA and raising with Management.
* To adequately identify any samples relating to Customer Complaints to allow traceability to the complaint file and vice versa.
* Identification of archive sample storage to allow timely sample retrieval in accordance with company procedure.
* To provide oversight of Solutions CAPA system, developing a system for monitoring CAPA investigations and corrective actions and co-ordinating activities to assist with their progression.
* Ensure that effectiveness of CAPA is performed according to review dates and that CAPAs are accordingly closed or re-opened as appropriate.
* To provide data related to customer complaints and CAPA as directed by the Quality Manager to support reporting of Quality Key Performance Indicators.
* Perform PMS activities to MDD and MDR requirements.
* To perform and report internal audits to support the internal audit plan and ensue completion and effectively of corrective actions raised from internal audits.
* Member of internal auditor team.

Knowledge & Experience:

* Computer literate, familiarity with and regular use of MS Office - Word, Excel.
* Ability to build and maintain internal and external working relationships.
* Well-developed communication skills to handle and convey complex information.
* Preferred Minimum of 2 years QA/QC experience within a Medical device or Pharmaceutical company.
* Diligent and good attention to detail.
* Highly organised approach to working.
* Experience and familiarity with Quality Management Systems for Medical Devices (ISO13485 & 21CFR820).
* Previous experience in complaints handling desirable.
* Previous experience of CAPA systems desirable.

Salary Range: £30,000 - £42,000 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.


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