QA Specialist

The QA Specialist will be a member of the Biologics Lab QA team that will provide support for the start-up activities, new product introductions and commercial manufacturing associated with unit.

This person will serve as the Quality reviewer and approver batch documentation, non-conformance and CAPA documentation, change control documentation, maintenance work order and job plan approval and other GMP documents.

The site is focused on continuous improvement of all work processes and practices and all colleagues are required to be flexible in this regard.

This means that they may be asked to carry out additional work functions that are not described in this specification but are associated with their role including;

Role and Responsibilities:
* Review and approve validation documents and summary reports
* Support execution of validation protocols by timely response to quality issues during execution
* Provide Quality oversight of change control records; ensure scope of record is clear and   implementation activities are completed according to plan
* Approve pre and post implementation plans
* May provide Quality perspective at Change Control Review Board (CCRB)

Requirements:
* University degree. Engineering or Science related discipline preferred
* Significant experience (4 years +) working in the pharmaceutical or biotechnology industry
* Excellent written and verbal communication skills
* Experience working with dynamic cross-functional teams and influencing decision

If this is you please apply today