Role Overview: 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.
- Carries out administration of the SAP Quality Management Module.
- Carries out tasks relating to the management of site change control systems.
- Compiles Annual Product Reviews.
- Supports all validation activities on site as described in the Site Validation Master Plan.
- 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.
- Excellent interpersonal skills
- Ability to operate as part of a team is critical.
- Customer focus
- Excellent communication skills both written and verbal
- Attention to detail
- Good problem-solving skills
- Results and performance driven
- Adaptable and flexible
- Decision making
For a confidential discussion and more information on the role, please contact Rory Walsh on 021 4911063 or email email@example.com
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