- Contribute to the quality assessment of a 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.
- 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
- Educated to third level in science-based discipline. Degree level preferable.
- At least 1-3 years of pharmaceutical experience in a regulated environment would be preferable. Experience in a 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.