Job DescriptionProvide oversight and management of key elements of the Quality Management System (QMS), which include, Supplier Quality Management and GMP training.
Supporting other elements of the quality systems group, including but not limited to, change control, deviations, CAPAS, documentation.Provide oversight and management of the supplier approval programme and the external audit schedule.Participate in the internal audit schedule.Administration/co-ordination of risk assessments.Develop and write SOP & Controlled Documents.Be a key member of the onsite audit team during external cGMP audits, e.g.
from Regulatory Authorities and Global Quality.Assisting in, and facilitating, investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs.Assist and co-ordinate the preparation of reports in relation to Annual Product Reviews for all products manufactured on site.To ensure that the systems with a GMP impact are maintained as per written procedures.Assist and co-ordinate implementation of global standards and procedures into the site Quality Systems.To actively support the development/implementation and continuous improvement of the Quality Management Systems.To be cross-trained in multiple quality systems.Participate in other projects as directed by the Quality Systems & Compliance Manager.Participate fully in any cross functional training initiatives.Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.Ensure timely completion of all SOP, reading, training and assessment.Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors.RequirementsBachelor's degree in chemistry, biology or a related scientific discipline.A minimum of 10 years working within quality in the pharmaceutical industry.SME in Supplier Quality Management and GMP training is desirable.Experience working in finished product pharmaceuticals/biologics, including analytical chemistry, quality assurance, quality control, development, and/or manufacturing areas.Thorough understanding of quality systems and cGMP's.Excellent verbal and written communication skills.Be self-motivated, flexible, organised and a good team player with the ability to prioritise own work based on departmental and site requirements.Work directly with other key departments to ensure compliance and productive working relationships.PackageExcellent benefits packagePerformance Related BonusHealth InsurancePensionFlexibility Paid Maternity/Paternity LeaveEducational Assistance ProgrammeZero Absence AwardTalent & Development ProgrammeOccupational Health & Wellness Programme