Our client, a global healthcare leader is keen to hire a Quality Specialist to join their team in Sligo on an initial 12-month contract. The Quality Specialist will assist in maintaining the quality system.
Responsibilities (Full job description available on request):
- Assist with administration and ensuring compliance to Quality Management Systems including Complaints, Batch Release, Exception Reports, CAPA, Document Control, Training, Label development, In plant Instruction development, Metric etc.
- Actively monitor Third Party Manufacturers data and Support areas for compliance with internal Standard Operating Procedures (SOPs) and relevant regulatory (cGMP, ISO) regulations.
- Review GMP related documentation for compliance such as batch records and associated data related to product manufacturing, testing and release, validation protocols and reports, labels, product specifications and other documentation as required.
- Participate in Corrective Action/Preventive Action (CAPA) process including the investigation of failures or deviations in the Manufacturing area as required.
- Write and revise SOPs, controlled forms, and related documents to ensure best practices and alignment with current operations.
- Collaborate with members of the Quality Assurance team working on special projects.
- Become familiar and subject matter expert on electronic support systems, Prima, GQMS, QDMS, compliance wire etc.
Ideal background:
- A third level certificate or higher qualification; or alternatively be educated to Leaving Certificate or equivalent level with a minimum of 1 years’ experience working in a regulated manufacturing or quality environment.
- Excellent interpersonal skills with the ability to work independently and in teams with infrequent supervision and reviewing.
For a confidential discussion and more information on the role, please contact Sarah Flynn.
sarah.flynn@collinsmcnicholas.ie
+353 719108060