Document & Change Coordinator

Document, Change and Records Control Management

• Applies Change Control, Documentation Control and Record Retention per 21 CFR Part 820, ISO ISO13485 and MDSAP.


• Provides guidance of Document, Change and Records Control Processes and Framework.


• Works cross functionally across sites to bring harmonisation and to ensure compliance and effectiveness of the Global Documents, Change Control and Record Management.


• Ensures that Global documents are routed, reviewed, approved, controlled, and implemented in accordance with established procedures.


• Reviews Global documents for accuracy and completeness in formatting and content.


• Ensures company records are retained and available for use in accordance with established procedures.


• Support internal and external audit activities including regulatory inspections i.e. (FDA Inspections) and ISO certification/surveillance audits.


• Proactive and flexible to adapt to a swiftly changing environment in regulations, methodology and technology.


• Establishes strong relationships with key stakeholders to foster compliance with Document Control and Change Control initiatives.


• For TrackWise Change Control Module: Identify and assist with the implementation of updates to the Change Control TrackWise module; including participating in validation efforts e.g., user acceptance testing.


• For Documentum Document Control Module: Identify and assist with the implementation of updates to the Documentum Document Control Module; including participating in validation efforts e.g., user acceptance testing.


• Ensure timely provision and reporting of metrics for Change Control and Document Control on a periodic basis.


• Advocate for Continuous Improvement.
  
  Intermediate skill level utilising electronic systems for management of the eQMS (D2 and Trackwise experience is desirable).


• Knowledge of the requirements and application of ISO 13485:2016, 21 CFR Part 820, and MDSAP.


• Ability to work in a fast-paced environment is crucial.


• Capable of working to challenging timelines and able to priotise multiple tasks but with the flexibility to meet changing needs and priorities of the business.


• Ability to communicate effectively in both oral and written communications, and work with employees at all levels of the organization.


• Ability to work without close supervision and produce quality work.


• Excellent computer skills: MS Office (Outlook, PowerPoint, Word, and Excel), and Adobe Acrobat Pro.


• Ability to communicate with diverse teams (R&D, Engineering, etc.) and functions to foster efficient processes, continuous improvement, and integration across the organisation.


• Excellent analytical, evaluative and problem-solving abilities.


• Desire to learn and a natural curiosity to understand systems and processes.


Qualifications/Education

• Bachelor's Degree in Life Sciences or related discipline preferred.


• Minimum 3 years supporting a global Quality Management System process in the medical device or healthcare industry.


Desirable

• Internal Auditor Qualification.
  
  Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Group revenues in 2022 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.com


Change is everywhere at Convatec. It's transforming our business, and helping us improve millions of lives. And we're nowhere near finished. Across every part of our business, we're pushing for better. Join us on our journey to #ForeverCaring as a Document & Change Coordinator, and you'll do the same.