Archiviertes Projekt - Senior Quality Expert QMS (m/f/d)

For our client in Hesse, we are seeking a Senior Quality Expert QMS starting in May (m/f/d) - 100% Remote.


 


Your tasks:


- Responsible for documentation management and archiving within the QMS framework


- Conduct QMS administrative work, including maintaining records, tracking metrics, and facilitating audits


- Design and implement DTI (Department of Information Technology) IT processes and controls, including IT Standard Operating Procedures (SOPs), Work Instructions (WIs), and systems


- Identify training needs for DTI IT personnel to execute assigned QMS functions effectively


- Develope training matrices and packages to support the qualification of IT personnel in implementing QMS processes


- Develope change management strategies, including PowerPoint decks, and communication plans to facilitate smooth transitions within the IT department


- Collaborate with cross-functional teams to ensure alignment of QMS processes with departmental goals


- Support continuous improvement initiatives by analyzing data and identifying areas for enhancement within the QMS


- Participate in QMS audits and inspections, addressing findings and implementing corrective actions as necessary


 


Your qualifications:


- Gained knowledge in GxP compliant documentation and quality management systems (ISO 9001, GMP, ISO 13485) as well as documenting computerized system validation and regulatory requirements (GMQ Annex 11, CFR 21 Part 11, GAMP)


- Understanding the method for the management of IT departments providing GxP system support/ management 


- Must be knowledgeable about FDA electronic records and electronic signature requirements, and all GAMP 5 software validation requirements


- 2+ years of professional experience working with or owning computer software validation/ system coordination


- Additionally, minimum of 5 years of professional experience working in a medical device or pharmaceutical industry as well as an international environment would be preferred


- Experience of working in a company manufacturing under GxP environment 


- Strong EN ISO 13485:2016 knowledge


- 21CFR Part 11 e-signature knowledge


- IT service provider/ department process awareness


- GAMP 5 software validation knowledge


- Relevant experience with Quality system IT Platforms – e.g. Trackwise, Windchill, Agile, IQVIA etc


- Knowledge of computer software validation and computer software assurance principals


- Knowledge and understanding of business systems, Windows Office, Teams, Projectplace, Visio etc 


- Basic familiarity with the production of medical devices or pharma products