Quality System Specialist - Audits
Would you like to be part of an organisation which is committed to improving patient lives worldwide through education, collaboration and innovation?
Do you want to make a difference?
If the answer is ‘yes’ then you’re just the kind of person we’re looking for!
You will be responsible for planning and scheduling the annual Internal or Supplier audit schedule and ensuring the Quality Management System (QMS) meets all current Regulatory requirements relevant to our business by planning, carrying out internal audits, reporting on findings, raising any NCRs or CAPAs found and follow up appropriately.
The successful candidate will be required to ensure that our supplier management system meets all regulatory and business requirements and that supplier qualification, audits and monitoring are appropriate for the products that they supply.
Principal Duties and Responsibilities:
NCR and CAPA
- Ensure all audit NCRs are fed through the NCR system as appropriate.
- Administration of NCRs and CAPAs on database including assessment of risk and escalation to corrective action.
- Aid with investigation of causes, aid with decisions to be taken and be able to set corrections/ corrective actions. To be able to offer direct assistance where required for large scale projects.
- Ensure any NCR/CAPA are followed up in a timely manner.
- To ensure overdue NCR and CAPAs are highlighted as a concern.
Auditing – Internal
- To ensure training received is in-line with IRCA registration requirements, to gain a thorough understanding of ISO13485, MDSAP and IVDR. To appreciate how clauses within different Regulatory standards relate to each other.
- To understand how these translate to our top level Quality Policies.
- To ensure our current auditing programme is suitable and meets the requirements of ISO/MDSAP and any applicable international requirements e.g. FDA/Health Canada/ JPAL/ Anvisa / TGA. Ensure the programme meets TBS requirements.
- Ensure audits are completed to schedule and NCRs and CAPAs are logged appropriately.
- Recording of all audits in the IFS AUDIT module.
- Ensure aware of updated standards and directives, ensure that our internal policies and audit programmes are updated to reflect new requirements.
Auditing – External
- Ensure that preparation and planning has been performed prior to the audit and the company is suitably prepared.
- To represent the company where required at external audits.
Supply Chain System Maintenance/ Supplier Audits and Critical Suppliers
- To ensure critical suppliers are audited to meet Regulatory and TBS requirements and ensure all supplier audits are carried out to schedule as intended annually.
- To ensure that our suppliers management system meets all regulatory and business requirements and that supplier qualification, audits and monitoring are appropriate for the products that they supply.
- Quality related agreements with suppliers are set-up, negotiated and managed according to the procedures.
Quality System Advisor
- Extensive knowledge of the details of the Quality System and be able to train others in Quality System requirements.
- Able to advise at all levels on any queries regarding Quality System requirements.
Essential:
- A Biological or chemical based degree (or equivalent).
- Qualified Lead Auditor.
- To have a full understanding of ISO13485 /IVDR / MDSAP.
- CAPA Management.
- Experience of working within a manufacturing environment.
- Audit planning, execution and follow-up.
- Good computer skills, Microsoft Office and database experience.
- The ability to manage multiple projects.
- The ability to Problem solve.
- Excellent attention to detail.
- Excellent communication skills both written and verbal
- The ability to work as part of a team.
- To be friendly and approachable.
- To be flexible to the needs of the business.
Working for us:
Founded in 1986 by a group of former researchers based at the University of Birmingham, The Binding Site is today recognised as a market leader in the development of products for the investigation of a range of disorders involving immunodeficiency.
The Company is built on the success of its people and provides the ideal environment to meet a wide range of career aspirations. It recognises the value of its employees and looks to provide development and support opportunities to maximise the potential of its 1,100 staff.
Working at Binding Site means being part of a global community that delivers innovative solutions with shared ideas and a collective dedication to improving patient lives, worldwide.
Location: Birmingham
Hours: 40 hrs
Benefits:
Competitive Salary
25 days paid holiday plus bank holidays
Medicash healthcare plan