Quality Assurance Executive

CPL

Dublin West

My client is a Global Pharmaceutical company based in Dublin West and is the process of building a new manufacturing facility and in conjunction with the CPL Group is looking to recruit for a Quality Assurance Executive. The Quality Assurance Executive (API) is responsible for managing the Quality Assurance team associated with production of oral solid dosage product production facility.As with all site personnel, the Quality Assurance Executive (API) is responsible for promoting a culture of Regulatory Compliance and Continuous Improvement within the Quality Department. Responsiblties. The responsibilities of the Quality Assurance Executive include the following: Management of the Quality Assurance team in the production facility. Management of batch disposition and material status control activities associated with API. Management of review of Batch Manufacturing Records (BMRs. Assisting in, and facilitating, investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs. Management of the Change Control process associated with ensuring controlled implementation of all GMP related changes. Management of QA oversight of routine manufacturing, testing and relating activities to ensure ongoing cGMP compliance. Ensuring effective participation of the API Quality Assurance team in production and other site meetings. Implementation of Key Performance Indicators within the Quality Assurance area to align with company and global quality objectives. Participation in the site Internal Audit programme. Participation in the preparation of, and hosting, external cGMP audits, e.g. from Regulatory Authorities and Global Quality. Participation in the preparation of documentation for regulatory submission and participation in regulatory affairs discussions. Taking a leadership role in promoting a culture of Compliance, Right First Time and Continuous Improvement. Implementing efficiency improvements in Quality Dept on a continuous basis and participating in site projects and initiatives. Communication and liaison with other TILGC departments on Quality issues (as required), providing guidance and support to others. Motivation, training, discipline and appraisal of Quality Assurance staff. Acting as a designee to the Quality Assurance Manager as required. EDUCATIONAL REQUIREMENTS: Primary Degree in a scientific discipline. RELEVANT EXPERIENCE: Minimum of 5 years' experience in the pharmaceutical industry in a Quality role. Experience of API manufacture is an advantage. Suitable applicants should email their cv to aileen.cahill@cpl.ie or call me on 01-6146007 for a confidential conversation today. This job originally appeared on RecruitIreland.com.

2385 days ago