Quality Lead, Validation

4 weeks ago

ireland TN Ireland Full time

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Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.


We are PCI.


Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

We are looking for a Quality Lead, Validation to join our Team in Stamullen, Co Meath.

Responsibilities:

Problem Solving and Investigation:

  • Ensure robust problem-solving methodology (e.g., root cause analysis, 5 Whys, Fishbone diagrams) is used to investigate validation deviations and larger issues seen on the packaging lines.
  • Lead cross-functional teams to address complex quality issues, ensuring comprehensive documentation of findings and corrective actions.
  • Develop and implement effective corrective and preventive actions (CAPAs) to resolve validation deviations and prevent recurrence.
  • Monitor the effectiveness of implemented CAPAs to ensure sustainable improvements.
  • Conduct thorough investigations into product non-conformances and quality issues, ensuring timely resolution and communication with stakeholders.

Continuous Process Verification:

  • Ensure a robust continuous process verification (CPV) program is in place and effectively feeds back into pFMEAs (Process Failure Modes and Effects Analysis) and risk assessments.
  • Regularly review and update pFMEAs and risk assessments to reflect current process knowledge and operational conditions.
  • Implement statistical process control (SPC) tools and techniques to monitor process performance and identify opportunities for improvement.
  • Develop and maintain key performance indicators (KPIs) to track the effectiveness of CPV activities.
  • Facilitate regular cross-functional reviews of CPV data to drive continuous improvement and ensure processes remain in a state of control.
  • Ensure that process validation and verification activities are aligned with current regulatory requirements and industry best practices.

Quality Assurance and Continuous Improvement:

  • Work with Quality Management to optimize QA performance and drive continuous improvement.
  • Identify and support opportunities for improving internal processes and/or procedures.

GMP Compliance:

  • Maintain compliance with GMP and client expectations as defined in Quality Agreements.
  • Ensure ongoing inspection and review of all logbooks and offline documentation used in the business unit is performed.
  • Perform GEMBA walks frequently to monitor housekeeping practices and evaluate GMP compliance.

Customer Interaction:

  • Participate in regular meetings with customers to ensure current business needs are fulfilled and support continuous improvement projects, including new product introductions.
  • Lead customer audits as required.
  • Become an area Subject Matter Expert on Quality matters relating to the process to assist in Customer and Regulatory audits as needed.

Facility and Utility Qualification:

  • Oversee the qualification of facilities, utilities, and equipment to ensure compliance with GMP and regulatory requirements.
  • Develop and execute qualification protocols (IQ, OQ, PQ) for facilities, utilities, and equipment.
  • Ensure that all utilities (e.g., water, HVAC, compressed gases) are qualified and maintained according to relevant standards.
  • Coordinate with engineering and maintenance teams to ensure ongoing compliance of facilities and utilities.
  • Lead temperature mapping activities for storage areas, warehouses, and transport vehicles to ensure compliance with regulatory requirements.
  • Develop and implement protocols for temperature mapping studies, including the placement of sensors and data collection methods.
  • Analyze temperature mapping data to identify trends and ensure that storage conditions remain within specified limits.
  • Implement corrective actions based on temperature mapping results to address any identified issues.

Project Management:

- Undertake tasks and manage specific or ad hoc projects as required to meet department and business needs.

Join us and be part of building the bridge between life changing therapies and patients.

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