Role of the Quality Assurance Manager

z Use

the word Manager, why? z Have you a job description? z Who are you reporting to?

Tissue, March 2007


Role of the Quality Assurance Manager The role must be:z Documented z Understood z Agreed z Reviewed periodically Job Description Tissue. March 2007 2 .

Article 17 (2004/23/EC) z Independence of role Tissue.Role of the Quality Assurance Manager z Quality control/ quality assurance z Responsible person. March 2007 3 .

March 2007 4 .Role of the Quality Assurance Manager Ensuring role is effective:z Included in the Management Team z Position is clear in the organisational chart z Involved in the strategic and planning process z Structure in place for Management Team meetings. Tissue.

Role of the Quality Assurance Manager Ensuring role is effective:z Role must be proactive rather than reactive z Direct reporting relationships must be practicable (i. March 2007 5 . availability) z Review processes must include the Quality Assurance Manager z Change management and communications systems Tissue.e.

Role of the Quality Assurance Manager Ensuring role is effective:z Where the tissue establishment is only part of the overall process (Hospital setting).Shared equipment .Shared facilities .Shared materials . it is important to identify and document:. March 2007 6 .Shared personnel .Shared methodologies Tissue.

Tissue. March 2007 7 .Role of the Quality Assurance Manager Group Workshop Exercise Draw up a job description for the Quality Assurance Manager in a:z Fertility Clinic z Peripheral Stem Cell Facility Using articles 17 of the Directive 2004/23/EC as a reference document.

Stored and Distributed in accordance with the requirements of Directive 2004/23/EC and Best Practice so as to ensure Quality and Safety. 4. Liaise directly with the Irish Medicines Board (IMB) as it applies to: -Regulatory Audits (Pre and Post) -Provision of information following major change to Personnel or Processes -The submission of the annual Report ( Tissue and Cells reconciliation report) -Reporting of Serious Adverse Events and Reactions 3. implementation and review of the Quality Management System to ensure Regulatory requirements are met and best practice is achieved. Preserved. the Quality Assurance Manager will be responsible for the following: 1. Stored and Distributed in accordance with the requirements of Directive 2004/23/EC. 1 . Procured. Section 1 Duties and Responsibilities Under the direction and control of the Clinical Director.Template 1 Job Description Tissue March 07 Job Description TITLE: REPORTING TO: Quality Assurance Manager (Responsible Person) Clinical Director Aim: The fundamental philosophy guiding this position is that the Post Holder will take any and all measures that will ensure that the Tissues and Cells are Donated. 2. Procured. Tested. Tested. To manage the activities of the Quality Assurance Function in the Tissue Establishment so as to ensure Tissues and Cells are Donated. Processed. In consultation with all staff to lead the development. Processed. Preserved. To participate in training a team of skilled staff and to promote healthy working relationships within the organisation.

To actively participate in and promote continuing education activities consistent with the position. Management of the controlled documentation and change control activities. Management and review non-conforming events including product recalls. Management of archived documentation/specimens/samples. Setting up and maintaining an Asset Register. 12. 16. 10. Management of Maintenance/Calibration Programmes for equipment and utilities including Service Contracts. 17. Perform induction training of new staff (Quality Management Training) 18. To perform any other functions which may be assigned by the Clinical Director 7.Template 1 Job Description Tissue March 07 5. 14. 9. 2 . Management of training traceable to the Training Plan. Writing. Management/ performance of the Internal Quality Audit Programme. 15. 11. 6. 8. To develop a system of risk assessment for the clinical areas. 13. customer complaints and internal non-conforming events. revision and review of Quality Management and Batch Release Procedures. Management of Validation Programmes for critical Equipment and Processes. Chairperson of Monthly Quality Assurance meetings and Annual Quality Management Review Meetings and providing reports as required to the Clinical Director.

or other health service business. To ensure cost effective use of all Quality Assurance staff and resources. patients or 3 . All annual.Template 1 Job Description Tissue March 07 19. Tissue Establishment HR policies are complied with. Human Resource Management ƒ ƒ ƒ ƒ ƒ ƒ ƒ Staff attendances are optimised in relation to work schedules. 20. To ensure that annual leave and study leave of all Quality Assurance staff are effectively scheduled to ensure the availability of cover at all times. examination. on no account must personal information concerning staff. Participate as appropriate in the recruitment and selection process of staff. parental and other leave is scheduled and recorded. Staff review and development is carried out for all staff. Implementing a system for the Documentation. To investigate customer complaints and provide a timely response in accordance with defined procedures. Review and Reporting of Adverse Events and Reactions. Setting up of Service Level Agreements with Third parties for Services that are relevant to the Authorization process Managerial Responsibilities • • • • To actively participate in formulation of policies. 21. Implement a procedure for the rapid recall of Tissue and Cells from Distribution. Tissue Establishment Health and Safety Regulations are complied with. clinical guidelines. Implement and foster a high level of moral amongst staff by effective motivation and communication. Section 2 Confidentiality In the course of your employment you may have access to or hear information concerning the medical or personal affairs of patients / staff. operational policy / procedures and the sharing of information. Such records and information are strictly confidential and unless acting on the instruction of an authorised officer.

. Article17 2004/23/EC Experience Personal Characteristics Skills 4 . In addition records must never be left in such a manner that unauthorised persons can obtain access to them and must be kept in safe custody when no longer required. which are pertinent to their employment. Article17 2004/23/EC At least 2 years practical experience. Signed:__________________________ Quality Assurance Manager Date: __________________________ Signed:__________________________ Clinical Director Date: __________________________ Note: This JOB DESCRIPTION is due for review no later than 2 years from the above date. Section 3. Professional Requirements Employees are required to submit all educational credentials including certificates / diplomas /degrees etc. Person Specification Essential Requirements Desirable Requirements Education A formal Qualification in the field of Medical or Biological Sciences.Template 1 Job Description Tissue March 07 other Tissue Establishment business be divulged or discussed except in the performance of normal duty.

_____________________________________________________________________ 11._____________________________________________________________________ 16._____________________________________________________________________ 17._____________________________________________________________________ 15.Workshop Exercise 1 Job Description Tissue March 07 Job Description Tissue Establishment Type: TITLE: REPORTING TO: Section 1 Duties and Responsibilities Under the direction and control of the________________________._____________________________________________________________________ 13.______________________________________________________________________ 6.______________________________________________________________________ 3.______________________________________________________________________ 8. the Quality Assurance Manager will be responsible for the following: 1.______________________________________________________________________ 2.______________________________________________________________________ 7._____________________________________________________________________ 12.______________________________________________________________________ 9.______________________________________________________________________ 5.______________________________________________________________________ 10.______________________________________________________________________ 4._____________________________________________________________________ 14._____________________________________________________________________ ________________________________________ Quality Assurance Manager (Responsible Person) ________________________________________ .

_____________________________________________________________________ Human Resource Management Responsibilities 26._____________________________________________________________________ 28.Workshop Exercise 1 Job Description Tissue March 07 Duties and Responsibilities 18._____________________________________________________________________ 23._____________________________________________________________________ 24._____________________________________________________________________ 29._____________________________________________________________________ 25._____________________________________________________________________ 30._____________________________________________________________________ 20._____________________________________________________________________ 27._____________________________________________________________________ 19._____________________________________________________________________ Additional Comments _____________________________________________________________________ _____________________________________________________________________ _____________________________________________________________________ _____________________________________________________________________ ._____________________________________________________________________ 22._____________________________________________________________________ Managerial Responsibilities 21.

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