Senior Quality Administrator

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.

Join Our Team as a Senior Quality Administrator - home based in Poland.

About this role

As part of our Quality & Compliance team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.

The Senior Quality Administrator is is a member of TFS Quality & Compliance and works closely with the team to ensure the efficient management of all aspects of the QMS including training, audit and legal.

Key Responsibilities: 

• Support work related to the development, implementation and daily management of TFS Quality Management System (QMS) to ensure continuous quality improvement and compliance with laws/regulations
• Quality Control (QC) and load QMS documents to MasterControl and work with the training team to release training
• Prepare and update the flowcharts within Standard Operating Procedures (SOPs) and other QMS Documents
• Track and manage QMS Document revisions
• Track and manage training tasks within the eQMS i.e. document archiving, training set-up, tracking, routine reporting etc.
• Manage the introductory programs for new staff i.e. Quality Induction
• Manage 3rd party vendors for training, close collaboration with training associations, clients, SMEs
• Manage the ticketing system for the team
• Maintain (i.e. on-board/off-board) users within MasterControl; resetting eSig passwords as required.
• Maintain Organizational Charts
• Manager Auditor Access to MasterControl and Palmyra, as required.
• Provide Training Reports for audits /Inspections
• Tracking / maintaining documentation of audits and Inspections to provide to clients.
• Manage/Provide Controlled Copies of QMS Documents.
• Maintain the qualified SharePoint site, Palmyra, for CSV documentation.
• Assist with the entry and tracking/management of Corrective Action Preventative (CAPA) and associated Action Items, as appropriate
• Prepare the weekly reports for Quality Events and training; send to appropriate staff. Prepare ad-hoc reports when requested.

Qualifications: 

• University/college degree or equivalent industry experience
• Awareness of the clinical trials area / pharma industry, including knowledge of GxP environment
• MasterControl experience preferred or relevant systems experience
• Highly-analytical professional with strong attention to detail
• Pro-active, recognizing and anticipating issues, addressing problems and developing solutions
• Good planning, organisation and problem-solving abilities
• Ability to work independently and efficiently
• Demonstrated ability to multitask, prioritize, and complete objectives
• Excellent proven oral and written communication skills
• Fluent in English, both written and verbal
• Advance user of MS Office applications (especially Word; Excel and PowerPoint

What We Offer

We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

A Bit More About Us

Our journey began over 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.