Tissue, March 2007 1

Role of the Quality Assurance Manager

Role of the Quality Assurance Manager
Use the word Manager, why?
Have you a job description?
Who are you reporting to?
Tissue, March 2007 2
Role of the Quality Assurance Manager
Role of the Quality Assurance Manager
The role must be:-
Documented
Understood J ob
Agreed Description
Reviewed periodically
Tissue, March 2007 3
Role of the Quality Assurance Manager
Role of the Quality Assurance Manager
Quality control/ quality assurance
Responsible person, Article 17
(2004/23/EC)
Independence of role
Tissue, March 2007 4
Role of the Quality Assurance Manager
Role of the Quality Assurance Manager
Ensuring role is effective:-
Included in the Management Team
Position is clear in the organisational chart
Involved in the strategic and planning
process
Structure in place for Management Team
meetings.
Tissue, March 2007 5
Role of the Quality Assurance Manager
Role of the Quality Assurance Manager
Ensuring role is effective:-
Role must be proactive rather than reactive
Direct reporting relationships must be
practicable (i.e. availability)
Review processes must include the Quality
Assurance Manager
Change management and communications
systems
Tissue, March 2007 6
Role of the Quality Assurance Manager
Role of the Quality Assurance Manager
Ensuring role is effective:-
Where the tissue establishment is only part of
the overall process (Hospital setting), it is
important to identify and document:-
- Shared personnel
- Shared facilities
- Shared materials
- Shared equipment
- Shared methodologies
Tissue, March 2007 7
Role of the Quality Assurance Manager
Role of the Quality Assurance Manager
Group Workshop Exercise
Draw up a job description for the Quality
Assurance Manager in a:-
Fertility Clinic
Peripheral Stem Cell Facility
Using articles 17 of the Directive 2004/23/EC
as a reference document.
Template 1 Job Description Tissue March 07
Job Description

TITLE: Quality Assurance Manager (Responsible Person)
REPORTING TO: 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, Procured, Tested,
Processed, Preserved, Stored and Distributed in accordance with the requirements of
Directive 2004/23/EC and Best Practice so as to ensure Quality and Safety.

Section 1
Duties and Responsibilities
Under the direction and control of the Clinical Director, the Quality Assurance Manager
will be responsible for the following:

1. To manage the activities of the Quality Assurance Function in the Tissue
Establishment so as to ensure Tissues and Cells are Donated, Procured, Tested,
Processed, Preserved, Stored and Distributed in accordance with the requirements of
Directive 2004/23/EC.

2. 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. In consultation with all staff to lead the development, implementation and review of
the Quality Management System to ensure Regulatory requirements are met and best
practice is achieved.

4. To participate in training a team of skilled staff and to promote healthy working
relationships within the organisation.
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Template 1 Job Description Tissue March 07
5. To actively participate in and promote continuing education activities consistent with
the position.

6. To perform any other functions which may be assigned by the Clinical Director

7. Management of the controlled documentation and change control activities.

8. Writing, revision and review of Quality Management and Batch Release
Procedures.

9. Management/ performance of the Internal Quality Audit Programme.

10. Management of training traceable to the Training Plan.

11. Setting up and maintaining an Asset Register.

12. Management of Validation Programmes for critical Equipment and Processes.

13. Management of Maintenance/Calibration Programmes for equipment and utilities
including Service Contracts.

14. Management and review non-conforming events including product recalls, customer
complaints and internal non-conforming events.

15. Management of archived documentation/specimens/samples.

16. Chairperson of Monthly Quality Assurance meetings and Annual Quality
Management Review Meetings and providing reports as required to the Clinical Director.

17. Perform induction training of new staff (Quality Management Training)

18. To develop a system of risk assessment for the clinical areas.

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Template 1 Job Description Tissue March 07
19. Implementing a system for the Documentation, Review and Reporting of Adverse
Events and Reactions.

20. Implement a procedure for the rapid recall of Tissue and Cells from Distribution.

21. 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, clinical guidelines, operational
policy / procedures and the sharing of information.
To investigate customer complaints and provide a timely response in accordance
with defined procedures.
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.
To ensure cost effective use of all Quality Assurance staff and resources.

Human Resource Management
Staff attendances are optimised in relation to work schedules.
All annual, examination, parental and other leave is scheduled and recorded.
Tissue Establishment HR policies are complied with.
Tissue Establishment Health and Safety Regulations are complied with.
Staff review and development is carried out for all staff.
Participate as appropriate in the recruitment and selection process of staff.
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, or other health service business. Such
records and information are strictly confidential and unless acting on the instruction of an
authorised officer, on no account must personal information concerning staff, patients or
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Template 1 Job Description Tissue March 07
other Tissue Establishment business be divulged or discussed except in the performance
of normal duty. 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.

Section 3.
Professional Requirements
Employees are required to submit all educational credentials including certificates /
diplomas /degrees etc., which are pertinent to their employment.

Signed:__________________________ Date: __________________________
Quality Assurance Manager

Signed:__________________________ Date: __________________________
Clinical Director

Note: This JOB DESCRIPTION is due for review no later than 2 years from the
above date.

Person Specification



Essential Requirements

Desirable Requirements
Education

A formal Qualification in the field
of Medical or Biological Sciences.
Article17 2004/23/EC




Experience

At least 2 years practical
experience.
Article17 2004/23/EC





Personal
Characteristics






Skills






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Workshop Exercise 1 Job Description Tissue March 07
Job Description
Tissue Establishment Type: ________________________________________

TITLE: Quality Assurance Manager (Responsible Person)
REPORTING TO: ________________________________________

Section 1
Duties and Responsibilities
Under the direction and control of the________________________, the Quality
Assurance Manager will be responsible for the following:
1.______________________________________________________________________

2.______________________________________________________________________

3.______________________________________________________________________

4.______________________________________________________________________

5.______________________________________________________________________

6.______________________________________________________________________

7.______________________________________________________________________

8.______________________________________________________________________

9.______________________________________________________________________

10._____________________________________________________________________

11._____________________________________________________________________

12._____________________________________________________________________

13._____________________________________________________________________

14._____________________________________________________________________

15._____________________________________________________________________

16._____________________________________________________________________

17._____________________________________________________________________
Workshop Exercise 1 Job Description Tissue March 07

Duties and Responsibilities

18._____________________________________________________________________

19._____________________________________________________________________

20._____________________________________________________________________



Managerial Responsibilities

21._____________________________________________________________________

22._____________________________________________________________________

23._____________________________________________________________________

24._____________________________________________________________________

25._____________________________________________________________________


Human Resource Management Responsibilities

26._____________________________________________________________________

27._____________________________________________________________________

28._____________________________________________________________________

29._____________________________________________________________________

30._____________________________________________________________________


Additional Comments
_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________

_____________________________________________________________________