|Role Type||Fixed Term Contract|
Job ID: JOB-11783
A leading pharmaceutical manufacturer is recruiting for a Quality Assurance Specialist to join their team in Cork on a FTC covering maternity leave
This role contributes to the implementation and maintenance of Quality Assurance actions in compliance with the current GMP regulations. In this role as part of a diverse team your primary responsibility will be for the quality assurance compliance activities in the Cork Site.
- Reviewing the GMP documentation e.g, SOPs, reports, methods, specifications, validation protocols, quality contracts etc., and Exceptional Documents e.g. NCRs/PNCRs, Planned Deviations etc.
- Writing and reviewing QA department procedures and reports e.g. protocols, SOPs, environmental reports etc. Reviewing and Approving other departmental procedures and reports.
- Internal Auditing (when required) of FLI Departments and external auditing (when required) of Material and Service Suppliers (including Supplier Management).
- Alerting the QA Compliance Manager in case of detection of a discrepancy / non-compliance.
- Participation in change control activities on site.
- Assisting in the preparation and reviewing of QA department reports and metrics e.g. monthly quality report, discrepancy reports, exceptions reports, KPI reports.
- Reporting and communication to QA Compliance Manager on key events and issues etc. via normal in house reporting structure e.g. meetings, formal reports etc.
- Participate in initiatives and action plans for the development of QA and improvement of GMP compliance.
- Participating and follow-up the audits and/or inspections carried out at the site by the authorities or clients
- Assist in preparation and presentation of GMP training programmes.
- Represent QA on BeX projects to ensure compliance to GMP
- Ensure QA activities are executed in line with in-house procedures and in compliance with 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 in-house and Global 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.
- Participate in KPI meetings to assist the batch release process.
- Educated to third level in science based discipline. Degree level preferable.
Technical Skills and Experience:
- Minimum 3 years pharmaceutical experience in a regulated environment would be preferable. Experience in pharmaceutical environment a significant advantage.
- Experience with Solid Dose
- Knowledge of GMP.
- Good organisation skills and time management.
- Analytical approach to problem solving.
- Proficient with Microsoft Word, Excel
For further information on this QA Specialist role in Cork please contact Clara Burke on 0868168273 or email@example.com
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