We're on the lookout for a dedicated and detail-oriented Quality Systems Specialist to join our client, a medical devices manufacturer!
This role is all about supporting quality and compliance systems while maintaining high standards across operations.
If you're passionate about continuous improvement and love working in a collaborative environment, we'd love to hear from you!
What you'll be doing:Take part in internal and external audit schedules.
Participate in third party audits.
Assisting with preparations for regulatory and customer audits.Administer/maintain and support the development/implementation and continuous improvement of the Stability Program.Support and develop Quality Management System, ensuring it meets ISO 13485:2016 standards and aligns with company's SOPs.
You'll also follow up on open items to make sure they're resolved.Manage and improve the system for handling on-hold or rejected materials, while also overseeing environmental monitoring.Coordinate risk assessments to ensure compliance.Keep SOP system running like clockwork by updating, logging, and distributing SOPs across the facility.Oversee complaints system, including pharmacovigilance processes, and ensure any issues are followed up and resolved.Keep Approved Supplier List (ASL) up to date and make sure suppliers meet the highest standards.Collate information and prepare reports in relation to Annual Product reviews for all products.Ensure all systems follow Good Manufacturing Practice.Support compliance with company procedures for controlled medical devices and help audit logbooks.Be a key player in identifying and implementing improvements as part of our Operational Excellence Programme.Handle sampling and inspection of packaging components and assist with any special sampling requests.Reviewing all manufacturing and packaging batch documentation, including electronic and paper records, for pharmaceutical and medical device products.Preparing Annual Product Quality Review reports.Managing and controlling the process deviation system, ensuring timely investigation and reporting.Overseeing the change control system, ensuring all changes are approved and implemented effectively.Coordinating investigations and responses to customer complaints within timelines.Reviewing and approving vendor files and liaising with suppliers to resolve complaints.Managing CAPA activities and participating in Risk Assessments and Root Cause Analysis.Generating and reporting Quality metrics on a monthly basis.Preparing and delivering GMP training modules and other training initiatives for plant personnel.Handling GMP documentation, including preparation, review, and approval.Managing Material Status Control activities and ensuring compliance with relevant procedures.RequirementsBachelor's degree in Science or a related pharmaceutical discipline.At least 3 years of experience in a Quality Assurance role within the pharmaceutical industry.Familiarity with EU quality-related pharmaceutical regulations.Working knowledge of GMP/GLP is not essential but desired.Strong knowledge of quality management principles and an understanding of operational excellence practices.Exceptional written and verbal communication skills, with a high standard of report writing.Strong IT skills and excellent organisational abilities.Good organisational ability and initiative to be able to work to and meet deadlines in a results oriented lab.Does it sound like you?
Please feel free to get in touch with our friendly team!
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