QA Validation Specialist
PE Global is currently recruiting for numerous QA Validation Specialists on behalf of a leading API company in Cork.
Job Description:
* 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.
* 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.
Requirements:
* Primary Degree in Science.
* 3-5 years experience in Quality/validation environment.
* Excellent attention to detail.
* Good communication, team work and problem solving skills.
* Good knowledge of relevant computer packages e.g. Trackwise, SAP and Vault Quality.
Company Information:
The duties of this role are generally conducted in an office environment and in a pharmaceutical manufacturing environment.
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