- Reference: CJ43704y
- Job Type: Contract
- Location: Cork, Cork City, Munster
- Category: Science, Pharmaceutical & Food
This position is responsible for carrying out tasks and projects related to management of Quality Assurance activities on site as required by Good Manufacturing Practice (GMP). These activities include Material release, Change control, Event management, supplier qualification, Annual product review and validation compliance activities.
Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met.
- Batch Record Review & material release to ensure compliance with GMP requirements.
- Carries out tasks related to the administration of event management systems including Review & Approval of Event, Deviations, and Customer complaints.
- Carries out tasks related to the management of batch records design and approval. Ensures that Batch Operating Instructions are compliant with filed descriptions.
- Carries out administration on SAP MRP.
- Carries out tasks relating to the management of site change control systems.
- Supports & GMP conducts GMP/ICH Q7a training as required.
- Compiles Annual Product Reviews.
- Supports all validation activities on site as described in the Site Validation Master
- Approves and compiles where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.).
- Supports system qualification and process validation activities.
- Reviews and approves SOPs/work instructions/forms from other departments on behalf of Quality Assurance
- Co-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site.
- Participates in the introduction of new process or modified process steps, as part of a New Product Introduction Team (NPI)
- Perform GMP audits on-site and vendor facilities as required.
- Carries out tasks related to the administration of site supplier approval process.
- Adheres to and supports the company safety policy and safety programmers.
- Engages in Site Credo initiatives
- Third level Scientific degree and at least 5 years QA or Validation experience.
For a confidential discussion and more information on the role, please contact Rory Walsh on 021 4911063 or email firstname.lastname@example.org
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