QA Specialist (Hybrid)

Summary:
A Pharmaceutical company based in South Tipperary requires a QA Specialist. The successful candidate will participate as functional expert in the cross functional team that manages production right first time. The incumbent will review and approve Quality System documentation. This is a hybrid role, that will required to work on site 2-3 days per week dictated by business needs (during site inspections 5 days on site is required).

Responsibilities:

• Participate as functional expert in the cross functional team that manages production right first time.
• Review and approve Quality System documentation.
  • Ensure that all Laboratory Out of Specification (OOS) and process deviations are documented, assessed and associated CAPA identified. Provide support to deviation investigations and process performance monitoring.
• Perform trending on deviations raised as required to identify improvement initiatives.
• Site Topic Lead for assigned Quality System Topics.
• Provide guidance on quality requirements to maintain validation status, including participation in process/product Risk Assessments.
• Provide detailed knowledge of quality systems in place and ensure that root cause is identified and corrective actions as appropriate are completed.
• Provide feedback on re-occurring issues ensuring continuous improvement to systems/processes.
• Ensure changes controls raised are documented, assessed and completed.
• Prepare Annual Process and System Reviews.
• Act as lead/team auditor to support the internal GMP walkdown and scheduled audits.
• Participate in the generation and communication of quality metrics.
• Creation, review and approval of quality procedures as required.
• Supports the implementation of site or capital projects by defining validation requirements and providing technical assistance and support as a member of the project teams.
• Develops Validation Summary Reports and assist in developing overall Quality plans for major projects.
• Works with other areas in operations and industry to predict future trends in validation and to determine best practice.
• SAP Quality Process Steward.
• PVC-Process validation committee point of contact.
• Quality SME for Change Control.
• Principle Quality contact for all site change requests (with impact on processing) – Provide Quality and change analyst review for all change requests through all the stages of the change control process ensuring compliance with operations and site policies, procedures and guidelines..
• Principle Quality contact for all Quality assessment of material control strategies associated with change requests for processing and analytical changes.
• Laboratory QA oversight – Support and approve the systems supporting laboratory functions, instrumentation and GLIMS.
• Provide Quality oversight and approval for laboratory incidents / investigations and documentation.

Qualifications & Experience:

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.
• 1 year’ relevant experience.
• Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise).
• Knowledge and demonstrated expertise in Lean / Continuous Improvement.
• Experience and knowledge of GMP Requirements for Electronic /paper free operations.
• Experience in any of the following: High potency/ Spray drying /Laboratory/ API/ Oral Solid Dose/ Project Management desirable.