Quality Assurance Specialist
3 weeks ago
Quality Assurance Specialist - Sligo
About the role:
Our Sligo based client are now hiring for a Quality Assurance Specialist to join their team. An excellent opportunity to work with a thriving Biologics/Pharmaceutical company offering great career progression opportunities. The Quality Assurance Specialist will be responsible for delivery of Quality Assurance activities to ensure the review and approval of validation documentation and activities related to the qualification of the facility, equipment, and utilities to support start-up and on-going projects working with cross functional Engineering teams.
Reach out for a confidential discussion:
contact Gary Keane
garykeane@cregg.ie
086-1030418 / 091-700814
Responsibilities:
- QA point of contact providing technical expertise, feedback and guidance for QA and compliance topics /issues including validation strategy /approach, new product introduction and manufacturing and assist in the resolution of issues commensurate with the level of risk.
- Perform timely review and approval of site procedures and documentation to ensure compliance with GMP and regulatory requirements.
- Review and approval of validation protocols/ reports and related documentation to ensure compliance with current EU regulatory expectations and site procedures.
- Ensure schedules for review and approval of GMP /validation documents are maintained to support technology transfers and new product introduction project timelines.
- Ensure application of Quality Risk Management principles as applicable.
- Act as the QA in QA activities in project work-streams involving cross-functional, multidepartment teams including Operations, Quality Control, Quality Assurance, Engineering, and others.
- Responsible for all associated documentation working on – CAPA, NCs, Protocols, Risk Assessments, SOPs, reviewing and approval. etc
- Actively contribute to continuous improvement activities.
Requirements:
- 3+ years' experience in the biotechnology, pharmaceutical, medical device or other GMP regulated industry,
- Third level qualification in relevant science and/or engineering discipline
- Experience working in a similar role in the Quality environment- strong documentation skills – CAPA, NCs, Protocols, Risk Assessments, SOPs, reviewing and approval. etc
- Strong understanding of GMP compliance and quality standards
- Excellent attention to detail and significant document review experience essential
- Effective time management and multi-tasking skills
- Demonstrate ability to drive the completion of tasks, trouble shooting skills and excellent attention to detail
- Excellent communication skills, both verbal & written.
- Collaborative Team Player
For more details or to find out more please contact Gary Keane
garykeane@cregg.ie
086-1030418 / 091-700814
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