Science & Pharmaceutical JobsQA Specialist (IMP)

  • CJ50149
  • Temporary/Contract
  • Cork, Cork City

Collins McNicholas

Role Responsibilities:

  • 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.

 

  • Implementation, maintenance and development of QA systems.

 

GMP documentation:

  • Reviewing the GMP documentation eg, SOPs, reports, methods, specifications, validation protocols, quality contracts etc.
  • Writing and reviewing QA department procedures and reports eg. protocols, SOPs , environmental reports etc.

Auditing and investigations systems:

  • By completing inspections and investigations in order to monitor factors which may affect product quality.
  • By alerting the QA Compliance Manager in case of detection of a discrepancy, anomaly or GMP practices discrepancy / non compliances.

Change control activities:

  • Participation in management and administration of change control activities.

Reporting and communication:

  • By assisting in the preparation and reviewing of QA department reports and metrics e.g. discrepancy reports, exceptions reports, KPI reports, and GMP Reviews
  • By reporting and communication 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
  • Represent QA on projects to ensure compliance to GMP

 

Meet the quality standards:

  • Ensure QA activities are executed in line with in-house procedures and in compliance with requirements of cGMP

Role Requirements:

  • Educated to third level in science based discipline. Degree level preferable.
  • Minimum 3 years pharmaceutical experience in a regulated environment would be preferable. Experience in pharmaceutical environment a significant advantage.
  • Knowledge of GMP. Good organisation skills and time management. Analytical approach to problem solving.
  • Word, Excel
  • Teamwork, flexibility, information gathering, execution, problem analysis & initiative

For a confidential discussion and more information on the role, please contact Josh Barnes on 021-4911066 or email josh.barnes@collinsmcnicholas.ie

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