Our client in Cork, a leading pharma company, are seeking an experienced QA specialist. This individual will contribute to the implementation and maintenance of Quality Assurance actions in compliance with the current GMP regulations.
With primary responsibility for the quality assurance in Operations and Manufacturing and the relevant supporting departments such as Laboratory, Validation, Engineering and Warehouse.
Product release activities
Review all documentation associated with batch release to ensure GMP compliance.
Ensure the follow-up of the necessary corrective actions & preventative actions implemented in consequence of a quality failure
Perform investigations, and ensuring a follow-up, following discrepancy, failures and external complaints.
Participate in KPI meetings to assist the batch release process.
Implementation, maintenance and development of QA systems.
Write and review QA department procedures and reports eg. protocols, SOPs , environmental reports etc.
Carry out the inspection, investigation, and taking of samples where appropriate, in order to monitor factors which may affect product quality.
Alert the QP in case of detection of a discrepancy anomaly or GMP practices discrepancy / non compliances
Participate in management and administration of change control activities on site.
Education & Training Educated to third level in science based discipline.
Degree level preferable.
Experience Minimum 3 years pharmaceutical experience in a regulated environment would be preferable. Experience in pharmaceutical environment a significant advantage.
Competencies Knowledge of GMP. Good organisation skills and time management. Analytical approach to problem solving.
Contact Brian Christensen on 01 6854747 or submit your CV to email@example.com for immediate consideration
If you would like further Information you can contact the recruiter directly:
Brian Christensen | Tel: +353 (0) 1 685 4747