Job Detail

Location Cork
Salary Negotiable
Posted
Role Type Fixed Term Contract
Contact Mark Wilson
email talent@hero.ie

QA Specialist

Job ID: JOB-11783
QA Specialist

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.

Key Responsibilities:

  • 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.

Education

  • 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 science@hero.ie

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Mark Wilson

JOB-11783

QA Specialist

Mark Wilson

Role Type Fixed Term Contract
Contact Mark Wilson
email talent@hero.ie
mobile +353 86 044 94 73
linkedIn profile click here

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