Quality Assurance Associate
4 weeks ago
Description
Title:
Quality Assurance Associate
Job Title: Quality Assurance Associate Job Purpose: The Quality Assurance Associate is responsible for the oversight and implementation of the Marken Quality Management System (QMS), Marken Standard Operating Procedures (SOPs), processes and policies required to manage and control Marken’s Storage, Distribution and Transportation, Kit Production Facility. The QAA also need to ensure compliance with applicable regional and local regulations and requirements, and customer requirements as appropriate, but not limited to: current Good Manufacturing Practice (GMP), Good Distribution Practices (GDP), Good Storage Practices (GSP), ISO 13485 and ISO 9001. Main Duties and Responsibilities Provide administrative support with basic tasks for ZenQMS Electronic Document Management System and Quality Systems Management. Provide support for ZenQMS Periodic Review. Assists in ensuring documents are maintained in a compliant manner throughout their life cycle. Ticket management for requests submitted to the ZenQMS helpdesk. Management of Complaints, Risk Assessment, Change Controls, Deviations and CAPAs, Audits and identify and implement quality improvement initiatives. Assist in writing quality assurance procedures as required for GxP compliance. Assist in performing internal audits including report preparation and assessment and tracking of associated corrective and preventive actions (CAPA). Assist in preparation of an external audit programme and perform audits of external service providers as part of the vendor selection process if required. Assist in hosting of client audits and regulatory inspections and manage the audit responses. Assist in vendor management, including updating list of approved suppliers in ZenQMS when vendor status changes. Identify relevant quality related training needs and deliver training where required. Effectively interact with local management and global stakeholders to maintain quality and help introduce new quality objectives. Communication, follow-up and escalation for outstanding issues and training and other administrative tasks as assigned. General Ensure compliance with national and international standard and legislation. Ensure timely and efficient management of records pertaining to the Quality Assurance Group. Travel as reasonably requested by the Line Manager for the performance of duties. Undertake any other reasonable duties at the request of the Line Manager Adhere to Good Manufacturing/ Distribution / Clinical Practices To adhere to all company Policies at all times. Requirements: Knowledge of Good Manufacturing Practice, Good Storage Practice, Good Clinical Practice and Good Distribution Practice guidelines. Minimum of 1 year of relevant experience working in a Quality Assurance role within a GSP/GMP/GDP/GCP regulated position. Associate degree and/or equivalent university degree/ certifications. Knowledge of local regulations. · Previous experience in Quality Management Systems with an eye for details. Excellent written and oral communication skills. · Fluent in English Good interpersonal skills · Organized, methodical and efficient approach to work. · Proficient use of Microsoft office. Marken is a wholly owned subsidiary of UPS and is a critical part of UPS Healthcare. Marken offers a state-of-the-art GMP-compliant depot network and logistic hubs for clinical drug product storage and distribution worldwide, and supports cell and gene therapy logistics services from clinical to commercial, while maintaining the leading position for Direct-to-Patient and Home Healthcare services, biological sample shipments and biological kit production. Moving Our World Forward by Delivering What Matters.-
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