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QA Specialist

20,264 P.A. ?
BR Recruitment Ltd


QA Specialist - 12 Month Fixed Term Contract

If you are keen to enhance your experience within an exciting and rapidly expanding International Scientific organisation offering a superb working environment, great training, benefits and careers, this could be the role for you!

An exciting opportunity has arisen in the QA Department for a QA Specialist (reporting to QA Supervisor)

Job Summary:

Assist in developing and maintaining a comprehensive quality management system to achieve inspection readiness for biopharmaceuticalproducts. Additionally, act as Quality Assurance support for client's distribution network.

Key responsibilities: -

·Develop, monitor, improve and maintain procedures to ensure compliance with EU/FDA Good Manufacturing Practice for the manufacture and testing of pharmaceuticals

·Develop, monitor, improve and maintain procedures to ensure compliance with EU Good Distribution Practice for pharmaceutical products

·Perform activities and reviews in accordance with relevant Standard Operating

Procedures, including but not limited to:

·Risk assessments

·Externally prepared documents


·Change requests

·Deviations (including Quality Investigations, EME's and OOS)

·Complaints (customer / supplier)

·Development Studies / Reports

·QMS data logs

·Room release documentation

·Batch record review (including PPRs, PTRs, MPRs and SPRs)

·Fill/finish documentation

·Product defect reporting and Quality Investigations

·Technical and Quality Agreements


·Perform batch review duties in accordance with relevant procedures, including issuing Certificates of Non-Conformance for bulk drug product and review of QC batch test folders

·Identify, investigate and report quality issues, escalating to management as required

·Participation in cross-functional projects

·Develop, implement and monitor Continuous Improvement activities

·Provide QA coaching / guidance for cross-functional groups to ensure compliance with KPI targets including functional QA if required

·Co-ordinate and provide training across functional groups in Quality Procedures, cGMP requirements and QA concepts

·Trend and report batch review and QMS data

·Provide support to management during third-party audits

·Perform internal housekeeping, in-process visits and quality audits

·Perform external quality audits, supporting local and sites

·Implement and maintain Quality Standard Operating Procedures, as required

·Train staff in QA related procedures and concepts as directed by line manager

·To undertake any other duties as requested by the line manager in accordance with company requirements

Essential Experience: -

·Educated to degree level in relevant qualification or relevant experience

·Proven and logical approach to problem solving

·Previous QA experience gained within a pharmaceutical / similar environment

·Experience working effectively in a team, influencing as appropriate

·Experience working within a GMP manufacturing environment

·Knowledge/experience of the requirements for distribution of pharmaceutical products

In return the successful candidate will be offered a highly competitive salary.

On application please advise re current salary, expected salary, re any applicable notice period

Please note that due to high levels of response, we may only be in touch with short listed applicants. Many thanks

This job was originally posted as www.totaljobs.com/job/90655323