Senior Quality Assurance Officer
|Job Title:||Senior Quality Assurance Officer|
|Salary:||£31000 - £36000 per annum|
|Contact Name:||Rachel Radford|
|Job Published:||January 17, 2017 15:04|
A client of mine are urgently seeking a Senior Quality Officer to join their manufacturing laboratory in Hertfordshire. Reporting to the QA Systems Manager, the main function of the role will be:
- To maintain Controlled Changes system.
- Generation of CofA documentation for customers.
- Download and review of temperature data for product shipments.
- Raise and investigate GDP incidents when required.
- Raise and investigate Customer Complaints.
- To be part of Document Control Unit, responsible for the creation, issue, copy control and recorded distribution of all quality controlled documents on the site.
In order to fulfil these functions, your responsibilities will include but not be limited to:
- To maintain the company's Controlled Changes system.
- To generate all QA documentation required for the shipment of product to Export Markets including Certificates of Analysis, Batch Protocols, Quality Certificates etc.
- To review and manage the use of data loggers used to monitor product shipments to all Export and UK Markets.
- To raise and investigate GDP incidents.
- To raise and investigate Customer complaints.
- Request, discuss and agree actions in response to a range of Quality events including deviations, plasma incidents, customer complaints, GDP incidents and controlled changes as required.
- Creation and revision of controlled documentation using approved procedures.
- Issue of unique identifications for controlled documents. Maintenance of the identification system.
- Issue and distribution of approved procedures and instructions, ensuring timely return of superseded copies.
- Preparation and recorded issue of procedures, batch records, forms and other controlled documents including equipment logbooks and laboratory notebooks.
- Maintenance of an electronic register of all controlled documents.
- Initiation and monitoring of document reviews and recall of obsolete documents.
- Ensure that procedures are complied with.
- To provide training on relevant Quality Systems when required.
- Motivating actions by other departments in order to obtain compliance improvements to corrective actions.
- Ensure that concerns regarding product safety and quality are drawn to the attention of colleagues and appropriate staff, including QA Management.
- To act as the point of contact between the company's QA and the QA departments of any agents/distributors or licence holders in Export Markets.
- To liaise with Regulatory Affairs and Marketing to ensure that products are only distributed to those territories in which the company is licenced.
- To be involved in customer/regulatory audits.
- To undertake QA inspections of facilities and activities.
- To undertake work related to Quality Assurance objectives as directed by QA Management.
If this role appeals to you please apply immediately!
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