QA Specialist - East Cork- Packaging
Pe Global
Cork
PE Global are currently recruiting for a QA Specialist for a client site in Cork - RESPONSIBILITIES: Performs a wide variety of activities to ensure compliance with applicable regulatory requirements. Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met. Maintains routine programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs. Reviews Packaging, environmental monitoring and quality control data for in-process and finished products. Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications. May participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products. May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products. Works with Research and Development during new product start-ups, and identifies checkpoints for new products and processes. Normally receives very little instruction on routine work, general instructions on new assignments. REQUREMENTS: Demonstrates proficiency in Good Manufacturing Practices (GMPs. Demonstrates proficiency in application of QA principles, concepts, industry practices and standards. Demonstrates knowledge of FDA / EMEA standards, and the interface with other functions like manufacturing, distribution and maintenance. Demonstrates audit and investigation skills, and report writing skills. Demonstrates knowledge of Batch Record and SOP review. Demonstrates strong verbal, technical writing and interpersonal skills. Demonstrates proficiency in Microsoft Office applications. Prior experience in pharmaceutical industry is preferred. Interested candidates should send their CV to Audrey.brennan@peglobal.net or call 0214297900. This job originally appeared on RecruitIreland.com.
2253 days ago