Science, Pharmaceutical & Food

QA Validation Specialist

  • Contract
  • Remote
  • Dublin North
  • 41937655

 

The role:

PE Global is currently recruiting for a QA Validation Specialist on behalf of our client based in Dublin. This is an initial 12 month contract role.

 

Position Summary:

The QA Specialist for Validation/Engineering will be responsible, with management support, for providing oversight of quality activities associated with the Packaging/Serialization, Engineering, Validation, Automation for routine operations and new product introduction for Finished Product and Medical Device/Combination Finished Products at Dublin.  This responsibility includes the oversight of the QMS to ensure that quality and compliance requirements are followed in line with business needs, including cGMP Biopharmaceutical and Medical Device quality standards.

 

Responsibilities:

  • Provide QA support for Risk-Based Verification (RBV) and Computer Systems Validation (CSV) activities in the capacity of Quality Assurance Subject Matter Expert.
  • Review and approval equipment/utilities verification documentation from design to post execution.
  • Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained/controlled.
  • Review and approve Validation protocols / reports as required.
  • Provide quality support for serialization of Finished Products
  • Support the vendor quality management program including generation and review of Quality Agreements
  • 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, including NPIs, for Dublin 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.
  • 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.
  • Provide Quality input, oversight and guidance to change controls, supporting risk assessments as required.
  • Review and approval of functional area documentation (SOPs, Packaging Instructions, Work Instructions, technical protocols and reports)
  • Define and report standard quality KPIs with recommendation for actions for improvement in relation to operations.
  • Supporting ‘right first time’ and continuous improvement from a systematic and compliance perspective

 

Qualifications

  • Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering)
  • Minimum 5 years in international Pharmaceutical and/or Medical Device industry with increased level of responsibility
  • Minimum 3 years of experience in QA technical role. Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements
  • 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
  • Good knowledge of relevant computer packages e.g. Trackwise, SAP, Tracelink and documentation systems
  • Planning and organizing skills are required to plan, execute and track commitments of Quality Assurance and to adjust to changing priorities

 

***Interested candidates should submit an updated CV to kellie.hackett@peglobal.net or alternatively call 021 4297900***

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