ASSISTANT QUALITY ASSURANCE MANAGER
| |
|
|
Job Reference Number |
14565980 |
Client ID: |
RI/AM12417 |
|
Posted On: |
Feb 6 2012 |
Location: |
MAYO |
|
Job Type: |
Permanent
|
Salary: |
NEGOTIABLE |
|
Assistant Quality Assurance Manager - County Mayo.
RESPONSIBILITIES:
' Lead the Quality Engineering Team
' Develop and advise on the continued development of quality systems and procedures for the area, including the development of product specifications / drawings / quality plans in conjunction with NPD personnel and the development of Master Validation Plans as required.
' Provide QE support for protocol studies and NPD projects
' Provides leadership in change management & in risk assessment, specifically process risk and capability analyses on processes
' Conducts, leads, or directs product complaint investigations.
' Coordinate the Corrective and Preventive Action (CAPA) program
' Provides leadership in facilitating internal and external audits and completes internal audits as per audit schedule
' Provides project leadership for implementing continuous improvement projects
' Provides leadership and resources for verifying and releasing finished goods into distribution
' Ensures training to FDA good manufacturing practices and ISO quality standards (including defect recognition)
QUALIFICATIONS AND EXPERIENCE SOUGHT:
Degree in Physical Science, Engineering, or other related discipline
Circa 10 years' quality engineering experience, including previous supervisory experience.
' Knowledge of applicable foreign and domestic regulations
' Knowledge of quality engineering tools and statistical quality control techniques
' Knowledge of quality auditing techniques
' Knowledge of process validation techniques
' Knowledge of project management skills
' Basic knowledge of sterilization.