Senior Quality Assurance Specialist
We are currently recruiting for a Senior Quality Assurance Specialist for a leading multi-national Pharma client based in Dun Laoghaire.
This is a contract position with an estimated salary of $120,000 per year.
Key Responsibilities:
* Provide overall quality direction and oversight for key functional areas including Packaging, Validation, Quality Control, Engineering, Automation & Information Systems.
* Quality review and approval of Validation documentation and SOPs to support site validation activities.
* Support a safe working environment by complying with all pertinent environmental health/safety practices, rules and regulations.
* Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records.
* Perform all activities in compliance with Amgen safety standards and SOPs.
Requirements:
* University degree in Science or Engineering related discipline.
* Relevant experience (7yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas.
* Understanding of principles of Validation and New Product Introduction.
* Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
* Able to operate across functional boundaries, both internal and external.
* Critical thinking skills.
* Strong organisational, communication, coordination, and meeting facilitation skills.