My client, within the pharmaceutical sector, is seeking a Quality Assurance Analyst to join their team to support them on an initial contract basis.
This role would be well suited to someone who has 6-12 months of Pharma Industry.
The Role: The successful candidate will report to the Director of Quality and will play a key role in supporting the development, implementation, and maintenance of the Pharmaceutical Quality System.
This position is crucial for ensuring compliance with regulatory standards and maintaining the highest level of product quality.
The Quality System Specialist will manage and oversee critical quality system elements including document management, supplier management, product dispositions, deviations, change control, Corrective and Preventive Actions (CAPA), and will support Quality Management Reviews (QMR).
Key Responsibilities:Quality Complaints Management: Handle the day-to-day processing of quality complaints, ensuring they are logged, investigated, and resolved in a timely manner.Document Management: Provide system approval for pre-approved documents as required.
Ensure accurate and efficient processing of documents through the electronic Quality Management System (eQMS).eQMS Administration: Support the administration and maintenance of the eQMS, including user training, troubleshooting, and continuous improvement initiatives.Supplier Management: Oversee supplier qualification and performance evaluation processes, ensuring compliance with internal and external quality standards.Product Dispositions: Manage product release and disposition activities, ensuring all products meet specified quality requirements before release.Deviation and Change Control: Track and manage deviations and change control processes to ensure they are documented, investigated, and resolved according to regulatory and company standards.CAPA Management: Implement and monitor CAPA processes to identify root causes of issues and ensure effective corrective and preventive actions are taken.Quality Management Review (QMR): Assist in preparing for and conducting QMR meetings, providing data and insights to support continuous quality improvement.
Required Qualifications & Skills:Experience: At least 1 year of office administration experience or a diploma/degree in a science-based discipline.Technical Skills: Proficiency in using software and web applications, with the ability to quickly learn and navigate new systems.
Familiarity with eQMS is an advantage.Communication: Strong verbal and written communication skills, with the ability to interact effectively with cross-functional teams.Attention to Detail: High level of accuracy and attention to detail in managing documentation and quality processes.Problem-Solving: Ability to identify issues, analyze data, and provide practical solutions in a timely manner.
