- QA review and approval activities for:
o Laboratory investigations and deviations and associated corrective actions.
o Contract testing laboratories investigations and associated documentation
o Operational SOPs, test methods, forms and directives
o Annual product reviews
o Trending reports
o Laboratory equipment/instrument qualification protocols and reports
o Protocols and reports for method validations and technical transfers
o Change controls - Establishing best practices and continuous improvement initiatives, in collaboration with Quality Systems and Compliance, to ensure compliance of all QC activities to all applicable policies, directives, guidance documents and regulatory requirements.
- Supporting the QC laboratory through global regulatory agency inspections and achievement of market approvals.
- Supporting the execution of the internal audit program.
- Supporting QC and QA Network Harmonisation initiatives.
- Minimum of a BSc in Science or related discipline.
- Minimum of 3 years Quality experience in the biopharmaceutical industry.
- A thorough understanding of cGMP requirements for laboratory compliance including equipment and instrumentation qualification requirements is essential.
- Excellent written and verbal communication skills.
- Ability to work on their own initiative in addition to working as part of a team.
- Ability to work across a team matrix in order to meet accelerated timelines.
- Excellent time management & organisational skills along with a proven ability to multi-task.
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QA Specialist - Dublin, Ireland - Headcount
Description
QA Specialist
An opportunity for a QA Specialist has arisen within a Dublin-based Biotech multinational. The QA Senior Specialist will support the development and implementation of the QA activities related to QC laboratory operations and QC site operations while also providing quality oversight for internal equipment qualification, method transfer activities, and QC site operations.
Key Responsibilities
Qualifications & Experience
For more information call Nicola on or email your CV in the strictest confidence to
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