QA Specialist
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| Job Type | ContractorFixed Term |
| Area | Cork, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #1002110 |
| Job Views | 612 |
- Description
- Do you want a career with attractive package and benefits and endless opportunities? We currently have an exciting opening for a QA Specialist to work on our client’s manufacturing facility in Cork. You will be working with a high performing team covering maternity leave. This role supports implementation and maintenance of Quality Assurance actions in compliance with the current GMP regulations. Your main responsibility will be for the quality assurance compliance activities in the Cork Site.
Why you should apply:
Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
The role is generously compensated, and attracts a competitive base salary and highly attractive benefits package.
Excellent career progression opportunities.
What you will be doing:
Reviewing the GMP documentation
Writing and reviewing QA department procedures and reports
Reviewing and approving other departmental procedures and reports.
Internal and external auditing on occasion of material and service suppliers.
Identifying non-compliance and alerting manager
Taking part in change control activities on site.
Helping in the preparation and reviewing of QA department metrics and reports.
Reporting and communication to QA Compliance Manager on key events and issues etc.
Contribute to development action plans for QA improvement of GMP compliance.
Participating and follow-up the audits and/or inspections carried out at the site by the authorities or clients
Help in preparation and presentation of GMP training programmes.
Represent QA on projects to ensure compliance to GMP
Ensure adherence of QA activities with in-house procedures and requirements of cGMP
SAP Local Key User for the QA Department
Support supplier activities (qualification, risk management and notification management) are executed in line with procedures and in compliance with requirements of cGMP.
Assist in New Product Introduction Activities when required.
Reviewing all documentation associated with batch release to ensure GMP compliance.
Verifying the labelling of the raw material, packaging components, bulk and finished product.
Ensuring the follow-up of the necessary corrective actions & preventative actions implemented in consequence of a quality failure
By performing investigations, and ensuring a follow-up, following discrepancy, failures and external complaints.
Contribute in KPI meetings to assist the batch release process.
What you need to apply:
Bachelors of science is preferable.
3 years + pharmaceutical experience in a regulated environment is ideal.
Knowledge in a pharmaceutical environment is desirable.
Experience with Solid Dose.
Knowledge of GMP.
Good organisation skills and time management.
Analytical approach to problem solving.
Good IT skills e.g., MS Office
