Senior Quality Officer

Brightwater

Waterford

The Senior QA Officer will manage and co-ordinate Quality Assurance activities and resources associated with the Pharmaceutical manufacturing and release of Products. You will be responsible for facility compliance with regulatory commitments, in-house requirements and cGMPs. This is a 2 year fixed term contract. About The Job: Responsible for facility compliance with regulatory commitments, in-house requirements and GMP. Introduction of quality systems by means of research and assessment of current industry practices and GMP requirements. Preparation of procedures and policies for area of responsibility. Responsibility for maintenance and development of GMP awareness facility-wide, including: preparation and execution of training programmes, assessment of GMP training requirements, and execution of internal GMP auditing. Investigation for QA review of all GMP critical documents. Participate and manage in the introduction and maintenance of GLobla Quality Management Systems (GQMS. In-house auditing. Line clearance procedures. Exception and deviation management e.g. deviations, Alarms, OOS, etc. Documentary review. Support quality aspects of materials management including supplier approval, supplier complaints and specification management. Maintain, develop and manage QA systems. Follow Standard Operating Procedures while carrying out duties at all times. Participate fully in all GMP and operational programs and complete all Training Records in an accurate and timely manner. About You. At least 5 years experience in a GMP regulated environment. Experience of scientific report writing including such documents as SOP’s, protocols, deviations, reports etc. Ability to evaluate and assess information to determine appropriate risk and required actions is critical. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.

1886 days ago