On Demand Quality Administrator

1 Year Fixed Term Contract

CityWest

The Role

The purpose of this role will be to support the business units with the administration workload for maintaining and updating the Quality Management System (QMS) required for Project Dawn and for SAP Extended Warehouse Management system EWM/ S4.

MAIN DUTIES & RESPONSIBILITIES

Act as Administrator for PROJECT DAWN, maintaining the Quality Management System (QMS) including develop, update, and maintain quality documents such as Standard Operating Procedures, Work Instructions and Quality related documentation in alignment with regulatory and business unit processes 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
Maintaining an efficient QMS system by logging training records, new procedures, quality records and other quality documentation onto the Q-Pulse system.
Inspection of Exempt Medicinal Products upon receipt into the warehouse to ensure compliance with quality standards and regulations
Coordinate and ensure completion of training programs for both new hires and existing staff
Responsible for the qualification and ongoing assessment of suppliers
Manage and update Quality Technical Agreements with relevant suppliers and vendors. New product assessment and approval
Participate in cross-functional projects and undertake additional duties as assigned by the Quality Manager.
Oversee the management and resolution of EMP product quality complaints and adverse event reports in accordance with internal procedures and regulatory requirements
Supports the quality team & quality projects as required.
Perform any other related duties assigned from time to time based on company needs.

QUALIFICATION, EXPERIENCE & SKILLS REQUIRED:

Third level qualification in a related discipline is preferred but not essential.
2 years’ experience in a GxP environment is preferred by not essential.
Ability to work in a busy, fast-paced environment.
Document Control: Managing SOPs, WIs, deviation reports, and quality records.
QMS Familiarity: Experience with Quality Management Systems like Q-Pulse or SAP. Data Analysis: Interpreting quality metrics and generating reports.
Excellent PC Skills, including Microsoft applications Word, Excel & PowerPoint, etc.
Internal Auditing: Supporting or conducting audits to ensure compliance.
Temperature Monitoring: Investigating excursions and maintaining logs.
Training Support: Assisting with GxP training and onboarding of new staff.
Multitasking & Organisation: Prioritising tasks, managing deadlines, and maintaining efficiency under pressure.
Ability to work in a busy, fast-paced environment.
Proactive and self-motivated.
Knowledge of Q-Pulse or similar electronic quality management software is preferred, but not essential.

COMPETENCIES

Knowledge of GDP: Understanding Good Distribution Practice (GDP) is essential for maintaining product integrity and regulatory compliance.
Attention to Detail: Precision is critical when handling documentation, monitoring processes, and identifying deviations.
Organized & efficient - with an ability to multitask and get the job done.
An ability to meet deadlines and an ability to prioritise and work under pressure.
Quality Culture Mentality: Commitment to "Right First Time" principles and a proactive approach to maintaining high standards.
Problem-Solving Skills: Ability to identify issues, propose corrective actions, and support continuous improvement initiatives.
Communication Skills: Strong written and verbal communication for reporting, training, and cross-functional collaboration.

On Demand Quality Administrator

Job Description