Senior Quality Assurance Professional

1 day ago

Dublin, Dublin City, Ireland beBeequality Full time €70,000 - €100,000

We are seeking a Quality Assurance Specialist to be the key point of contact and decision-maker during New Product Introductions, Technology Transfer, and Process Validation activities for Aseptic products.

 

The successful candidate will ensure that all activities meet company and regulatory expectations by reviewing and approving process development and validation documentation, technical transfer documents, validation protocols, executed validation documents, and reports.

Quality direction and input at Change Control and Deviation Review Boards will also be provided by the Quality Assurance Specialist. This role assumes QA oversight of change control and Deviation/CAPA records, ensuring scope of record is clear and implementation activities are robust and timely.

To excel in this role, you must have a university degree in a science or engineering-related discipline and 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.

Experience in aseptic manufacturing, change control, non-conformance, corrective and preventative actions, and validation practices is necessary. Strong organizational, communication, coordination, and meeting facilitation skills are essential, along with independent, self-motivated, organized, and able to multi-task in project environments and skilled in communication and collaboration.

As a team player, you are prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.

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