QA Specialist - QC

PE Global are looking for a QA Specialist (QC) on behalf of our client based in Dublin:

12 Month initial contract

Position Summary

The QA Senior Specialist for Quality Operations will be responsible, with management support, for providing oversight of quality activities associated with Quality Control at ADMF. This will include the responsibility for quality oversight of the QC testing. He/she is responsible for ensuring that testing, packaging, labeling, and storage of products comply with all applicable regulations. This includes clinical and commercial products. This responsibility includes the oversight of the QMS to ensure that quality and compliance requirements are followed in line with the business needs.

Principal Responsibilities

Responsible for the quality oversight for Quality Control (QC) related activities for testing activities, method transfer, method validation, retain and stability program. This includes raw materials, clinical and commercial products for Drug Substance, Drug Product, and Finished Product

• Responsible for quality oversight of QC certificate of analysis
• Provide QA oversight and guidance of change controls, Laboratory Investigation Reports, deviations, Quality Control SOP's, method transfer documentation, validation and qualification documentation and test related documentation
• Ensure quality KPIs in relation to QC activities are met
• Provide Quality input, oversight and guidance to deviations and investigations to ensure robust root cause analysis/CAPA definition and timely closure as per SOPs and QMS
• Responsible for Quality oversight, with management support of internal packaging and warehousing. Support the QP team, in relation to preparation and review of the relevant documentation for the QP release pack and release schedule
• Perform batch documentation review, management of changes, complaints, deviations, validations and product annual reviews
• Provide oversight to continuous quality system improvements and support implementation of improvements in compliance, Preventive Maintenance, Deviation Management and the Change Control Programs
• Provide QA and compliance support to projects impacting on testing and packaging

Activities

• Provide support and expertise for inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions
• Responsible for quality review and approval of Quality Control SOPs, Master Packaging Batch Records in accordance with internal procedures and GMP principles
• Review and approval of standard operating procedures and controlled documents
• Define and follow up standard quality KPI and to review quality indicators with recommendation for actions for improvement in relation to Quality Control and packaging operations
• Participate in quality risk assessments and provide quality oversight to ensure quality risk assessments are effectively maintained/controlled.

Education and Key Competencies

• Minimum 5 years in international pharmaceutical and/or biotech industry with increased level of responsibility
• Experience in Quality department, QC/QA is preferable
• Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements
• The person in this position will be able to work off their own initiative
• Demonstrated success records in auditing and improvement processes
• Ability to operate efficiently in a complex matrix organization and international environment
• Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels
• Primary degree in Science (Chemistry, Microbiology or Pharmacy preferred)
• Efficient in SAP, EQV, ECMS, LIMS