QA Specialist (Pharma Analytics)

Recruiter
Anonymous
Location
Cardiff
Salary
30000.00 - 40000.00 GBP Annual + GBP30000 - GBP40000/annum
Posted
17 Mar 2017
Closes
30 Mar 2017
Function
Analytics
Contract Type
Permanent
Hours
Full Time
Just Life Sciences are an Independent Life Sciences recruiter based in Cardiff, providing Permanent and Contract staff to the Life Sciences Sector in Wales,

We are seeking highly skilled individuals who will be assisting the Quality Management team in ensuring that Analytical activities on the site are in compliance with current Good Manufacturing Practice standards and in accordance with company policies to meet business requirements.

Working with primarily, the Analytical Services department you will provide QA guidance and expertise in the resolution of quality issues.

A diverse role you will be expected to

To play a lead role in the interpretation of business and regulatory (MHRA, FDA) guidelines and QA systems for input into compliance enhancement projects for facilities, processes and products, and to approve technical reports / protocols where appropriate.
To promote a sense of quality throughout the site departments so as to raise Analytical Services performance and eliminate waste caused by unnecessary compliance errors.
To conduct internal performance audits and follow up actions within site business units.
To lead nominated regulatory compliance projects and to ensure that the business meets its regulatory commitments through satisfactory completion of these projects.
To assist in the hosting of Client audits.
To review non-compliance identified by audit, deviations and complaints, and use technical / professional judgment to make the appropriate product quality decisions (in association with Quality Management), and to initiate and promote quality improvements to prevent re-occurrence.
To ensure the review and approval of all documentation relating to manufacturing to support their continued processes to meet the business needs.
To ensure that products were tested in accordance with specified requirements and cGMP.
To provide input to statistical trending reports on quality key performance indicators and to initiate corrective and preventive actions based on this data. To generate a monthly report on the key activities and key performance indicators for the area.
Experience

You will have significant experience in the pharmaceutical industry, with a diverse knowledge of various analytical techniques and experience of staff supervision.

Experience of working within a Quality Department within a cGMP/pharma environment.

Excellent written and verbal communication skills are required by the job holder as in the course of the duties. The job holder will need to communicate with personnel outside of the Quality group, with external clients, regulatory bodies and consultants.

The job holder will need to have excellent analytical problem solving abilities and be able to lead by example and get results through persuasion and co-operation.

Experience of GMP auditing to relevant quality standards with potential to perform audits

Qualifications

Educated to degree level or equivalent in a science or quality assurance related discipline, and ideally be a member of a professional body as recognised by the UK MHRA. (A lower level aligned qualification plus significant QA pharma industry experience would also be considered).

If you are interested in this role or a seeking a career with the Life Sciences Sector then please contact

justyn withey at justlifesciences dot com