Job Description
This is a 12-month initial contract based onsite in Athlone. Purpose The QA Validation Specialist performs review and approval activities to support validation activities in cGMP commercial and clinical requirements for the Company. The responsibilities will include reviewing and approving validation documents such as policies, master plans, procedures, specifications, investigations, protocols, and reports. Responsibilities Maintain 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 approve 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 reports 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 program. 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 Post-graduate studies as appropriate to augment the primary degree 3-5 years experience in Quality/validation environment. Drug Product and Drug Substance experience Excellent attention to detail Good communication, teamwork and problem-solving skills The duties of this role are generally conducted in an office environment and in a pharmaceutical manufacturing environment. As is typical of an office-based role, employees must be able, with or without accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem-solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours. As is typical of a pharmaceutical manufacturing-based role, employees must be able, with or without accommodation to: frequently lift/carry 15/30 pounds unassisted/assisted; stand for prolonged periods of time; walk and move for prolonged periods of time; climb stairs or ladders; gown/degown PPE and uniforms; use a computer with a keyboard and mouse; collaborate with others. Skills: QA Validation Asceptic Fill Finish Experience Drug Substance Experience