QA Specialist - PTQA
- Dublin
- Contract
- Full-time
- Quality review and approval of Process Development and Validation documentation:
- Technical transfer documents
- Validation Protocols, executed validation documents and reports
- Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
- Perform all activities in compliance with company safety standards and SOPs.
- University degree - preferred 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 (i.e. Process Development, Validation, Manufacturing)
- Understanding of principles of Validation and New Product Introduction.
- Experience in aseptic manufacturing.
- Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
- Ability to operate across functional boundaries, both internal and external.
- Ability to work independently and remotely with minimum direct supervision.
- Critical thinking skills.
- Strong organizational, communication, coordination, and meeting facilitation skills.
- Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration.
- Team players are prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.