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Quality Manager - Pharma

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Waterford
  • Sector: Science
  • Date posted: 12/01/2018
  • Job reference: J379885A

QUALITY MANAGER - PHARMA

Principle accountabilities:

To manage the compliance within the dept. and ensure that the area is operating in accordance to GLP

To provide support on any external investigations

To lead continuous improvement activities and support projects

Assist in any validation activities that may as the Quality representative within the project

To oversee the product and process performance using appropriate metrics Quality representative on the sign-off of change controls, documentation and validation activities

Lead projects for the introduction of new equipment within the site, ensuring that the correct level of validation is completed, that the relevant procedures are updated, and that there is a training plan in place

To approve all reports generated due to any investigational work that is requested due to a complaint or a potential issue within the manufacturing site. To ensure that the data generated is accurate and generated in a timely manner to help close out issues and potentially release product

To ensure that the procedures are up to date and in compliance to the global systems. To ensure that the records generated are accurate and completed in real time

To review method validation protocols and reports on new/ existing test methods, as required

To approve all reports generated due to any investigational work that is requested due to a complaint or a potential issue within the manufacturing site. To ensure that the data generated is accurate and generated in a timely manner to help close out issues and potentially release product

Requirements:

 

Experience of scientific report writing including such documents, protocols, deviations, reports etc

Have managed a QA department for 5 years in Pharmaceuticals

Ability to evaluate and assess information to determine appropriate and required actions is critical

Good knowledge of Tablet manufacturing desirable

Knowledge of purified water and Environmental Monitoring systems

Full understanding of the requirements of the Regulatory Standards

Degree in chemistry, science or related technical discipline

 

For a more detailed role description or information on other positions, please contact Kathryn on 01-6455244 / 087 3555378 or