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The role (in a nutshell)
The Quality Assurance Officer will be responsible for helping to administer the Quality Management System and helping ensuring it adheres to GxP activities and ISO standards. This role is involved in the completion of internal audits, maintenance of the standard operating procedures and reporting of complaints and serious incidents to the customer as well as looking at opportunities for continuous improvement.
This role will require the successful candidate to be based in Bedford with occasional travel to other sites
Undergraduate degree or relevant equivalent experience.
A Quality professional with experience in a quality control environment.
Consultancy and partnership skills, including negotiation and influencing skills; proactively building relationship with others to achieve results
People Management skills
Ability to work effectively within a team as well as independently, exercising a high degree of autonomy.
Excellent analytical and numerical skills. Ability to use statistical and other data to produce high level reports.
Excellent written and IT skills, with the ability to accurately & clearly document specifications / manuals
Excellent customer service skills.
PRIMARY DUTIES & AREAS OF RESPONSIBILITY
To be responsible for maintenance of the ISO 9001 and GMP/GDP Quality Systems including training of staff in SOP’s, non-conforming product investigations and management of deviations
Good knowledge/understanding of GMP regulations and guidelines
To provide high standard of administrative support to enable the Quality Department to work within a framework of continual Quality Improvement
To investigate, resolve and report corrective and preventative actions as required, including logging and investigation complaints and equipment issues using the QA ticket system.
To provide support to Quality Manager/QP for any filling plant deviations or quality improvements
Provide assistance in management of ISO /GMP/GDP audits and creation of records as required.
Performance of internal quality audits for ISO and GMP/GDP and where appropriate external audits for suppliers
Assistance in creation of monthly quality business reports and assessing compliance to KPIs as required by the Quality Manager
Manage all aspects of Serious Incident Requiring Investigation (SIRI) investigation including follow up of QA tickets to ensure completion prior to Quality Manager sign off
To be involved in the participation and completion of agreed projects involving the Quality function to provide a quality input and help participate and complete any specific agreed project objectives.
To assist QP with investigations including scanning batch record paperwork to QP/Contract QP when they are offsite
If this sounds like something YOU have experience in and would like to get involved with then apply today!! Needed ASAP.
Thank you for your interest in this vacancy, which is being advertised by Osborne Appointments, who are acting as an employment agency / business. Your application will be considered in competition with others and we will contact you within 3 working days. Should you wish to speak to one of our team, please contact the OA Bedford office on 01234 347069..
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