Validation Manager Job in Sligo, Sligo Ireland

 

A.            DEPARTMENT FUNCTION/OBJECTIVE

 

To coordinate the development and execution of the Project’s validation program in compliance with all applicable regulatory and company requirements.

 

B.            PRIMARY FUNCTION:   

 

The Validation Manager shall be responsible for developing validation as well as integrated commissioning and qualification plans and reviewing and approving commissioning and validation documents in accordance with current GMPs. This individual will determine and develop approaches to resolve complex validation issues

 

The Validation Manager must possess excellent verbal and written communication skills and the ability to communicate validation requirements, timelines, and resource needs to management. The Validation Manager will work closely with the project team members such as Engineering, and the Quality Assurance Group, to incorporate the appropriate elements of quality and production into validation strategies.

 

 

C.            MAJOR DUTIES AND RESPONSIBILITIES: 

 

·         Lead the validation of project equipment, utilities, processes and software in compliance with FDA, European cGMP and GAMP standards.

 

·         Update of the Validation Master Plan

·         Generation/maintenance of Project Validation Plans.

 

·     Generation of validation protocols and final reports to cGMP standard.

 

·         Review / approval of all protocols and final reports.

 

·         Management of validation change control process.

 

 

D.            SUPERVISORY OR MANAGERIAL RESPONSIBILITY

                                                                                                                                                               

 

Ø  Contact with Personnel within the plant at all levels.

Ø  Contact with internal and external auditors, e.g., FDA, IMB

                               

E.            EDUCATION:                      Indicate applicable minimum education requirements

 

3rd level qualification in engineering or scientific discipline.

 

 

F.             EXPERIENCE:   

 

A minimum of 7 years experience in a cGMP regulated environment with at least 3 years working in a validation lead role

 

G.            PROBLEM SOLVING:     

 

This position is crucial in identifying systems requiring validation and ensuring that this activity is documented, actioned and resolved.  Good communication and motivation ability is required.

 

 

H.            ACCOUNTABILITY:       

 

This position impacts on product quality and technical performance as well as manufacturing.

 

 

I.             SCOPE OF AUTHORITY:

 

Decision making within confines of agreed responsibility.  Activities broadly defined by agreed impact goals.

Contact: Michael McElduff 0874181507