QA Validation Specialist

The role:

PE Global is currently recruiting for numerous QA Validation Specialists on behalf of a leading API company in Cork. These are all initial 12-24 month contract roles.

Responsibilities:

• Maintenance of a strong Quality culture throughout the project through operational activities.
• Provide QA support for risk based verification activities in the capacity of Quality Assurance Subject Matter Expert. Review and approval equipment/utilities verification documentation from design to post execution.
• Lead and/or participate in the investigation of non-conformances and follow-up corrective/preventative actions in compliance with quality procedures, policies and regulations.
• Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained/controlled.
• Ensure and participate in the Quality Assurance support to internal manufacturing and technical groups. Review and approval of functional area documentation (SOP, Work Instructions, Criticality Assessments, technical report and protocols).
• Authoring, review and approval of QA validation -related procedures.
• Review and approve Validation protocols as required. (Examples include cleaning, process, and method validation).
• Support the vendor quality management programme.
• Complete Audits as required.
• Develop and report quality metrics for validation/verification.
• Provide quality oversight of calibration and preventative maintenance criticality assessments as required.
• Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.

Education and Experience:

• Primary Degree in Science
• 3-5 years’ experience in Quality/validation environment. 
• Excellent attention to detail
• Good communication, team work and problem solving skills
• The duties of this role are generally conducted in an office environment and in a pharmaceutical manufacturing environment.
• Good knowledge of relevant computer packages e.g. Trackwise, SAP and Vault Quality

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***