Associate Manager QC Compliance

Brightwater

Limerick

One of the most dynamic Biopharma sites in Munster has a vacancy for an ambitious QC Specialist to oversee metrics in its high performing laboratory. This is a permanent role with a strong salary and benefits package that offers a clear progression path. This could be the move that defines the arc of your future career. About the Job: Oversee all QC inputs into quality systems including laboratory invalids, general investigations, deviations, CAPAs, change controls, Inspection readiness items and inspection responses. Report quality system metrics to the wider Quality Control group and identify improvements that can be made in all quality system inputs. Coordinate QC training activities. • Ensure that all activities related to the investigation and resolutions of non-conformities are performed in a timely manner and in compliance with procedures and regulatory requirements. • Report Quality Control metrics associated with data generated and quality system to regulatory agencies and Quality Control managers. • Assist Quality Control personnel in meeting timelines associated with investigations, deviations, corrective and preventative actions and change controls. • Provide feedback to Quality Control personnel on trends that have been identified within the quality system. • Assist in the development of Compliance Specialists to understand quality system inputs and provide support to Quality Control personnel in completing tasks. • Oversee Quality Control’s coordination of subject matter experts during regulatory inspections. • Co-ordination of inspection outcomes and associated responses where necessary in accordance with the required timelines. • Oversee the training plan for Quality Control personnel and ensure the necessary training and documentation is in place prior to deployment for GMP activities. • Coordinate with the Technical Training department regarding training content, delivery and metrics and ensure that activities are appropriately tracked. • Provide an employee, manager or regulatory agency with the necessary information regarding Quality Control employee OJT. • Represent the department on Quality Control Training topics. • Preparation and delivery of the local Right to Operate Quality control information. • Co-ordination of Department meeting schedule and material. • Develop and maintain the QC capacity planner. About you: • BS in chemistry, biology or related field with 7+ years’ experience in quality control/quality assurance required. • Managerial experience required with the ability to handle multiple responsibilities between the Training and Compliance teams. • Requires excellent written, verbal and interpersonal communication skills and the ability to effectively interact with all levels to communicate negative information and obtain positive results. • Ability to effectively interact with regulatory inspectors. For more on the role call Nigel on 021 4221000 or send your CV for consideration. This job originally appeared on RecruitIreland.com.

1919 days ago