We are currently recruiting for a Quality Assurance Technician to join our team. This is an exciting opportunity with a leading Pharmaceutical organization based in Carlow.
The Quality Assurance Technician will be responsible for ensuring the quality of site's systems, processes and controls. They will be accountable for contributing to ensure that objectives are effectively achieved, consistent with regulatory requirements to ensure compliance, safety & reliable customer supply.
Responsibilities
1. Comply with and execute Good Manufacturing Practices (GMP) in the performance of day-to-day business activities.
2. Ensure data integrity principles: Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) are adhered to for records and data in day-to-day business activities.
3. Liaise with the Quality Leads to resolve quality related queries where required
4. Ensure that adequate processes and procedures are in place and followed for all Quality activities.
5. Provide support to the relevant support functions to ensure manufacturing and release activities, in compliance with applicable procedures, global policies and regulatory requirements.
6. Identify and support compliance initiatives to improve compliance status and overall operational efficiency for batch release at the site.
7. Support business critical projects related to the Quality Department.
8. Use process principles and tools to identify and support continuous improvement by active participation to ensure quality systems and work practices are effective, efficient and ensure compliance and overall operational efficiency for batch and material release at the site where required.
9. Provide quality support of controls and procedures for the end to end material and product lifecycle where applicable.
10. Assist team members to support the qualification/validation, technical transfers, and commercial operations at the facility where required.
11. Supports the Laboratory and team members with day to day activities, as applicable.
12. Ensure compliance to regulatory requirements.
13. Assist team members with tasks relating to SOP's, deviations, cleaning verification/validation data and other documents as necessary for the Quality and Manufacturing departments where required.
14. Contribute to effective writing/revising/rolling out of accurate operational procedures, training materials and maintenance procedures for various Quality related systems