Description
OBJECTIVES:- To provide support to the Manufacturing Quality Manager in maintenance, review and improvement of the Quality System.
- To oversee the product development process from a quality perspective.
- To provide quality management oversight of the validation process of new or development products.
- Review and author validation documentation as required.
KEY RESPONSIBILITIES:
- To review and approve validation documentation associated with product development activities.
- Track and trend validation activities associated with development products.
- Ensure that validation product is properly controlled, segregated and identified.
- Ensure that non-conformances are tracked through CATSweb (Common Automated Tracking Software)
- Provide guidance from a quality and regulatory perspective to the validation team.
- Provide updates to the site Plant Quality Plan as required.
- Ensure that cGMP are followed at all times
- Maintain good documentation practices for Work instructions, SOP's and Forms.
- Additional requirements of the job will be specified by the Manufacturing Quality Manager.
EXPERIENCE REQUIRED:
- Third level Qualification in Science or Engineering.
- Minimum 5 years experience in a regulated pharmaceutical/medical device environment.
- Experience in product development.
- Experience in validation.
- Experience in using Microsoft Office products.
- Experience of team working.
This is an exciting opportunity to join an excellent company. If you would like to apply for the role please contact Sarah Irvine on or alternatively apply via this advert.