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QA Officer

Job Title: QA Officer
Contract Type: Permanent
Location: Hertfordshire
Industry:
Salary: £20000 - £25000 per annum
Start Date: March / April 2017
Reference: 68883-PHARM-JHY_1488533190
Contact Name: James Harvey
Contact Email: James.Harvey@volt.eu.com
Job Published: March 03, 2017 09:26

Job Description

Job title: QA Officer / Archivist
Job type: Permanent
Location: Hertfordshire, North of London
Salary: £20,000 - £25,000 / year + company benefits

Background

* My client is a leading Bioanalysis contract testing laboratory with an enviable history of supporting pharmaceutical companies with analytical expertise as well as clinical study support
* They have an exciting opportunity to join them on a permanent basis in an interesting and varied capacity primarily as a QA Officer & Archivist but also supporting other company activities as required

Job Summary

* To maintain expertise in conducting QA audits and archiving studies in compliance to GLP and GCP regulations using the MHRA, OECD, EMA and FDA guidelines
* To help other members of staff in their compliance to these regulations

Key Responsibilities

* To be a deputy Archivist and a QA officer to help the company maintain an efficient and robust and compliant GLP/GCP data archive
* To conduct process, facility and study audits as requested by the line manager
* To understand all the requirements of a Study Director in the whole process of method development, assay validation and analytical support from protocol to final report including category allocation and archive generation
* To ensure that at each stage of any procedure, the jobholder has a strategy of making checks to try to eradicate any possibility of error
* The jobholder has the responsibility to ensure that all work audited by them conforms to GLP and GCP and to biological and chemical safety regulations (COSHH)
* To understand how to use computers and their associated software and hardware to process and report analytical results
* To effectively communicate with superiors, all staff and sponsors on the progress and the results of all work under the jobholders' responsibility
* To write and update 'Standard Operating Procedures' for which they are designated or deputy designated person
* To instigate new systems or maintain existing systems for risk assessment, change control and CAPA
* To maintain the company's asset list and other equipment, reagent, chemical sample and sponsor logs
* Make sure that training records are being maintained and instigate systems

Other Information

* The job holder hours can be flexible but if full time employment 37.5 hours (9am to 5pm Monday to Friday) is required then the ideal job holder will not only work as an archivist and QA officer but also help the Laboratory and QA Manager/Archivist and the other members of staff in the operation and maintenance of an efficiently run company

* The job holder must be a non-smoker due to the nature of the samples in test

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