QA Specialist
Harmonics Recruitment
Clare, Limerick
Experienced QA Specialist required for a top pharmaceutical company based in Limerick. This is a permanent, full time position, offering excellent salary and benefits. Summary : The QA Specialist for Manufacturing Operations provides QA oversight to ensure that drug substance manufacturing activities are compliant with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Standard Requirement Documents. Responsibilities: Prepares appropriate documentation and executes release of acceptable product lots and vendor materials. Reviews completed manufacturing, filling, and labeling records, and analytical data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria. Reviews, edits, and approves deviation notifications, deviation investigations, and corrective actions. Reviews, edits, and approves change control and SOPs. Reviews, edits, and approves new and revised master manufacturing records. Reviews, edits, and approves validation protocols and executed protocol reports. Audits production and other departments for quality system effectiveness. Performs hands-on monitoring of production and non-production activities and notifies area and Quality Management of any observed non-compliance. Education and Experience: Requires BSc/BEng in scientific discipline or related field. 3+ years of relevant work experience in pharmaceutical or related industry. Biologics manufacturing experience highly desirable. Adaptable and flexible, willing to work shift as needed. For more information on this position or any other technical position please contact Rachael O’Rourke on 061 336 136. This job originally appeared on RecruitIreland.com.
2466 days ago