15829358-QA Validation Specialist-Athlone Contractor

This is a 12-month contract.

Purpose:

The QA Validation Specialist performs review and approval activities to support validation activities in the Company’s cGMP commercial and clinical requirements for the Company’s Manufacturing Facility. The responsibilities of the incumbent will include performing review and approval of validation documents such as policies, master plans, procedures, specifications, investigations, protocols, and reports.

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 of 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.

Minimum Qualifications & Requirements:

• Post-graduate studies as appropriate to augment the primary degree
• 3-5 years of experience in Quality/validation environment.
• Drug Product and Drug Substance experience
• Excellent attention to detail
• Good communication, teamwork and problem-solving skills