Quality System Specialist Audit Team ManagerWest MidlandsPermanent role competitive salary and benefits packageAre you an experienced Quality specialist with an understanding of the Audit process?...
Quality System Specialist - Audit Team ManagerWest MidlandsPermanent role - competitive salary and benefits packageAre you an experienced Quality specialist with an understanding of the Audit process? My client is a multinational biotech company with a successful product portfolio and healthy pipeline developing diagnostic equipment for the diagnosis of certain cancers. They are looking to expand their QA department with an experienced audit team manager who has experience of the audit process and of managing a team for this senior role within Quality Assurance.The successful applicant;
- You will have a proven record of involvement and leading internal and external audits
- You will have experience with management/supervision of a team within a QA environment and the ability to positively influence others
- You will have experience working within a manufacturing environment or QA department
- You will ideally have experience of NCR and CAPA or knowledge of ISO and FDA quality system regulations.
The Role and responsibilities;
- You will ensure all audits are carried out as scheduled.
- You will be responsible for the creation of annual compliance plans alongside the following;
- Creation of audit plans
- Carry out periodic audits as a lead auditor. To be able to
- highlight non conformance
- Write an audit report and add to ERP audit
- Be able to complete and close audits on ERP system
- Responsibility for creation of NCR, scoring and CAPA for internal audits and following NCRs up.
- Able to produce audit reports for circulation after audit, and final report after audit closed
- To be able to deliver IFS System Training for Audits.
- To be able to produce QSRM reports when required.
- Internal Spot Check 5S Audits
- Responsible for ensuring there is a suitable documented procedure in place for this system
- Responsible for planning, scheduling and carrying out these audits
- Creation of annual supplier audit scheduleEnsure sufficient auditors are available to conduct supplier audits to schedule.
- To carry out supplier audits where required
- To oversee the Supplier Management/audit/review and ensure that procedure is being correctly followed at all times
- Review of status of system with the QA Specialist responsible for Supplier Management.
- Responsibility for ensuring that the supplier list is reviewed, up to date, ensuring critical suppliers are being reviewed and audited to target requirements.
- To represent the company at external regulatory and customer audits.
- Ensure all audits are planned and appropriate resource has been scheduled.
- Coordinate action plans in response to regulatory audit findings.
To discuss this role further or for an informal chat about the position please call Oliver on 0121 7288454 or email .
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.