Job ID: JOB-11558
Qualified Person/QA Specialist
My client a leading pharmaceutical company is recruiting for a Qualified Person/QA Specialist to join their diverse Quality team in Cork.
In this role you 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 compliance activities you will act as Qualified Person for the Cork site.
Through the Release of Finished and Semi-Finished Products you will act as a Qualified Person in compliance with the regulatory and legal requirements of this title.
- You will contribute to the Quality Assurance Plan Realisation through participation in Quality and process improvement initiatives as required.
- Be a key collaborator on the Implementation, maintenance and development of QA systems.
- Review GMP documentation eg, SOPs, reports, methods, specifications, validation protocols, quality contracts etc, and Exceptional Documents eg. NCRs/PNCRs, Planned Deviations etc.
- Be responsible for writing and reviewing QA department procedures and reports eg. protocols, SOPs , environmental reports etc. Reviewing and Approving other departmental procedures and reports.
- You will play a key role with Auditing and investigations systems.
- Be involved in Internal Auditing (when required) of FLI Departments and external auditing (when required) of Material and Service Suppliers (including Supplier Management).
- Alert the QA Compliance Manager in case of detection of a discrepancy / non compliance.
- Participate in change control activities on site.
- Assist the preparation and reviewing of QA department reports and metrics eg. monthly quality report, discrepancy reports, exceptions reports, KPI reports.
- Report and communicate to QA Compliance Manager on key events and issues etc. via normal in house reporting structure eg. meetings, formal reports etc.
- Participate in the development of the quality standard across the site
- 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
- Environmental Monitoring – review of data, monthly report , NCRs, Annual Report
- Assist in New Product Introduction Activities when required.
- Contribute to the quality assessment of clinical, pre-commercial product, and IMPs
- Product release activities
- By reviewing all documentation associated with batch release to ensure GMP compliance.
- By verifying the labelling of the raw material, packaging components, bulk and finished product.
- By 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.
- You will have a relevant A third level Bachelor’s Degree in Chemistry or related Science discipline
Technical Skills and Experience:
- Experience to requirements for position of Qualified Person as defined in EU GMP volume 4 and annex 16.
- Previous management / supervisory experience an advantage
- Experience of GMP auditing and documentation.
- Ability to critically assess issues and execute problem solving
- Fluent written and verbal English
For further information on this QP role in Cork please contact Clara Burke on 086 8168273/ firstname.lastname@example.org
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