£ 20000 - £ 22000 / Year
Office and Secretarial - Administrator
· Job type
Office and Secretarial
· External Reference
The role is primarily to manage the internal ISO/quality audit schedule. This will include auditing ISO 9001:2015 (quality) across the business. All non conformities and opportunities for improvement raised during the audits will be logged on a central system and it will be the responsibility of the quality auditor to not only update this log but also manage the resolution of every non conformance, working with Managers and Supervisors to come to satisfactory conclusions and also auditing that in practice, these solutions are being carried out effectively. This role is all about continual improvement with the role holder being a key asset in helping the business not just meet but exceed its aim in delivering a quality and safe service.
Whilst operational quality will remain the focus of this role, there will also be opportunities to branch out into auditing and managing compliance within the pharmaceutical quality system, across all medicinal gases manufactured by the client specifically Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP).
Due to the nature of the business, this department is also heavily involved in information governance and data protection. Experience of ISO 27001:2013 and more generalised information governance & data integrity requirements are desirable although full, on the job training shall be given to accommodate this aspect of the role. Knowledge or experience working in the medical device sector would also be desirable although not mandatory to fulfil this position.
The ideal candidate shall work closely with the Quality Manager, on other audit requirements such as management reviews, external ISO audits with our audit partner NQA and external MHRA (Medicines and Healthcare Regulatory Agency) GxP inspections.
The ideal candidate will need to be a team player but also confident at working independently and able to display a level of tact and consideration which will be required when dealing with potentially difficult issues arising from audit. They must also be approachable, eloquent and pragmatic - working with staff across the business to resolve any problems which may arise. Good literary skills will be required as each audit conducted will need to be written up in a report, in a clear but detailed (where necessary) way. Good organisational and planning skills are also key in carrying out this role effectively.
List major responsibilities in each category below that impact this job. Focus on the key functions that take up most of the job's time. Do not attempt to list all the activities.
· ISO 9001:2015 auditing across the business.
· GxP auditing across all Medicinal Gas manufacture and storage
· ISO 27001:2013 auditing across the business
· Non-conformance, corrective and preventive actions tracking, working with Managers to resolve any issues
· Maintaining audit deadlines, providing prompt updates and completing in line with a schedule
· Be aware and pragmatic in terms of non conformance resolution where financial issues could play a role
· Will be expected to work with others positively with the ability to influence others as required
· Must be a team player and approachable
· Representing the ISQ department (the compliance function) internally
· Reinforcing compliance with regulatory standards (ISO, GxP etc)
Adecco acts as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. The Adecco Group UK & Ireland is an Equal Opportunities Employer.
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