Argenta Dundee have an exciting opportunity for a Quality Assurance Specialist on a Fixed Term Contract for 12 months. This role would be ideal for an experienced QA Specialist who has worked across a variety of manufacturing dosage forms and is confident within a QMS framework.
This role is responsible for the co-ordination and maintenance of the quality framework and systems ensuring the compliance of documentation for all GxP across the Dundee facility, reporting into the Quality Assurance Manager.
Your key responsibilities will include :
Hands-on maintenance and improvement of the current QMS to ensure continued compliance both in terms of internal processes and with external customers
Work closely with other departments to implement the necessary actions to maintain compliance to current systems for change controls, CAPAs, deviations, complaints
Evaluate and review of Change Control Requests, ensuring compliance with cGMP and quality standard requirements. Hold weekly meetings and follow up on recommended actions
Evaluate Customer Complaints. Progress complaint investigations with the required cross functional teams ensuring adequate and timely closure
Reviewing and Assessing validation and qualification documents
Track Key Performance Indicators for the quality system processes, review and monitor trends, communicating out-of-norm issues to department management
Prepare and present quality reports, data and Key Performance Indicators to management for review at quality review meetings and annual product quality reviews.
Support the Quality Manager in conducting and leading the Management Review Meetings
Assisting the internal quality training, determining training needs and perform GMP compliance / quality training
Utilise quality tools and techniques to perform and document full root cause investigations, to evaluate and resolve quality issues, and to enhance continuous improvement
Participate in the Site’s Vendor Management Programme
Update, maintain and improve quality management system process documents and review and approve manufacturing batch records
Your background, experience and attributes will include :
Bachelor's degree in science, pharmacy, biological science or related field is desired
Hands-on Quality Assurance experience in pharmaceutical / biotech industry
Strong understanding of cGMP requirements and the ability to implement this within the QMS
Strong understanding of QMS Deviations, Change Controls, CAPA, risk assessment etc.
Excellent interpersonal, verbal and written communication skills
Ability to work well in teams or independently
Ability to prioritise work and manage multiple projects while maintaining quality and compliance