QA Specialist - East Cork

Pe Global

Cork

PE Global are currently recruiting for a QA Specialist for a client site in Cork - QA Specialist (12 month contract. RESPONSIBILITES 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) and Good Laboratory Practices GLPs. Reviews manufacturing, 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. REQUIREMENTS: Specifically this role is required to act as the QA representative on the MES upgrade Project, previous experience of Computer System Validation whilst advantageous is not mandatory. Demonstrates a high degree of attention to detail. Demonstrates good verbal, written, and interpersonal communication skills. Demonstrates problem solving skills. Demonstrates proficiency in Microsoft Office applications Oracle environment. Demonstrates strong verbal, written, and interpersonal communication skills. Specific Education & Experience Requirements. Demonstrates an ability to lead a standard investigation with minimal supervision. Demonstrates an ability to effectively communicate with cross-functional peers. Keeps abreast of the basic requirements for compliance in own work area. Some years of relevant experience in the pharmaceutical industry. Interested candidates should send their CV to Audrey.brennan@peglobal.net or call 0214297900. This job originally appeared on RecruitIreland.com.

2261 days ago