QA Lead

Pe Global

Kildare

PE Global are currently recruiting for a QA Lead for one of our pharmaceutical clients in Kildare. This is a permanent role. Responsibilities of the role: Ensure strict adherence to site policies/procedures, cGMP/GLP and environmental, health and safety regulations. Ensure area of responsibility is maintained in a constant state of compliance and audit readiness in line with current regulations, PQS, and business needs. All related procedures and documentation are maintained accordingly. Execute responsibilities in line with Right First Time principles. Ensure resolution of and/or appropriate escalation of issues. Provide subject matter expertise and support for systems, technologies and products. Identify Continuous Improvement opportunities and progress Continuous Improvement projects. Responsible for area budget preparation and management. Support the introduction of new products. Batch Release and Document Management. Making appropriate decisions with respect to product quality, safety and efficacy utilizing the site Quality Operations Lead as the final arbitrator on critical quality decisions. Provides Quality oversight on Change Controls. Provides direction to Customer Complaint Investigations. Management and oversight of the Stability Program. Co-ordination of the Annual Product Record Review Process. Quality oversight for raw materials, packaging component, in-process product and supplier qualification. Selection and recruitment of colleagues. Ensure colleagues are appropriately trained for their role, and a training curricula exists for colleagues. Ensures an active performance management system is operated within the area in order to meet business and compliance needs. Coach colleagues in the completion of their tasks. Day to day management of colleagues including, timekeeping, leave, and adherence to company policies and procedures. Operation of HR Source as required. Education and Experience required: Third level Qualification Degree or higher in Science related discipline. Experience in both QA and QC. Five years experience in a Pharmaceutical Management position. Eligibility for Qualified Person status. Experience in solid oral dose is essential. Ability to interact in a corporate environment and proven leadership qualities. If you are interested in this position, please forward your CV to catherine.osullivan@peglobal.net. This job originally appeared on RecruitIreland.com.

2188 days ago