Quality Administrator

Quality Administrator Full Time 1 Year Specified Contract CityWest Objective The purpose of this role will be to provide administrative assistance & support cross functional entities within the Pharma division instilling a culture of GxP & quality awareness within the Quality & Pharmacovigilance Departments & to ensure compliance with the requirement of ISO 9001, GxP regulatory and principal requirements including continuous updating & maintenance of the company’s Quality Management & Pharmacovigilance System. Main Duties & Responsibilities Act as Quality Administrator, maintaining an efficient QMS system by logging training records, new procedures, quality records and other quality documentation onto the Q-Pulse system. Maintain the Quality Management System (QMS) including managing SOPs, update, review & approve Standard Operating Procedures, Work Instructions and Quality related documentation, as required, troubleshooting the QPulse system and notify colleagues of SOP’s requiring updates. Prepare weekly, monthly, quarterly & annual reports and/or reviews, as required. Support Quality Agreements Deviations, Risk Assessments, Change Controls & CAPAs, including participation in investigations. Deliver induction and routine training regarding Company Quality & Pharmacovigilance policies and procedures. Communicate any identified gaps to maintain compliance and identify process improvements. Perform the day-to-day activities of Pharmacovigilance (PV) including registration of Adverse Events, Product Complaints and customer complaints ensuring appropriate follow-up with all relevant stakeholders (e.g. supplier, patient, quality team, etc.). Support in all ISO required activity to ensure continuous maintenance of the company’s ISO Standard. Maintain the highest quality, compliance and safety standards. Build positive and professional working relationships with all relevant company personnel. Supports the Company quality team & quality projects as required. Keeps abreast regarding all aspects of the role i.e. procedures, compliance and regulatory matters. Perform any other related duties as assigned from time to time based on company needs. Qualification, Experience & Skills Required Third level qualification is preferred but not essential. Minimum of 2 years’ experience in a similar quality administration role is preferred but not essential. Excellent PC skills, including Microsoft applications Word, Excel & PowerPoint, etc. Knowledge of Q-Pulse considered an advantage, but not essential. Ability to work in a busy, fast-paced environment. Demonstrated ability to drive the completion of tasks. Knowledge of Q-Pulse or similar electronic quality management software is preferred, but not essential. Experience of working in a GxP or ISO environment considered an advantage, but not essential. Competencies Customer and commercial focus, able to ensure customer requirements are understood and delivered. Excellent verbal & written communication skills. Sound attention to detail. Excellent telephone manner. Highly organized & efficient - with an ability to multitask and get the job done. Excellent interpersonal skills - with an ability to positively interact with all relevant personnel. An ability to prioritise and work under pressure. Problem Solving. Collaboration & Proactivity. An ability to meet deadlines. Knowledge of ISO & GxP, industry standards, and pharmaceutical sector. Please note that Uniphar is an equal-opportunity employer; we do not discriminate and welcome all responses. #J-18808-Ljbffr Dormont Manufacturing Co