Quality Assurance Specialist and QMS Manager
vor 4 Wochen
Objective of the Role:
The Quality Assurance Specialist and QMS Manager plays a pivotal role in assisting senior Quality Specialists to ensure the successful execution and upkeep of the Quality Management System (QMS) within the IT division. This position emphasizes operational support across a range of quality assurance functions to maintain standards and compliance.
Key Responsibilities:
- Support quality assurance protocols, including the management of documentation and compliance with established procedures.
- Provide input for the design and execution of IT processes and controls within the QMS framework.
- Engage in the design and documentation of IT processes and controls, ensuring they meet quality standards and objectives.
- Compile and generate reports related to quality metrics, process performance, and compliance indicators.
- Implement established processes and controls, adhering to defined procedures and guidelines.
- Assist in training initiatives by contributing to the development of training materials and documentation.
- Remain updated on certification requirements pertinent to the services offered by the IT department and inform relevant stakeholders accordingly.
- Identify roles and responsibilities within the QMS framework, aiding in the definition of clear accountability and ownership.
- Support system inventory management, including asset tracking and maintaining accurate records.
- Collaborate with senior Quality Specialists to resolve issues, implement enhancements, and foster continuous improvement of the QMS.
- Participate in QMS audits and inspections, providing necessary support and documentation.
- Contribute to the documentation of processes, procedures, and best practices within the QMS.
- Assist in the development and upkeep of documentation repositories and knowledge bases.
- Acquire knowledge in GxP compliant documentation and quality management systems (ISO 9001, GMP), including the documentation of computerized system validation and regulatory requirements (GMP Annex 11, CFR 21 Part 11, GAMP).
- Understand the management methods for IT departments providing GxP system support/management.
Education & Qualifications:
- Bachelor's degree in Computer Science, Software Engineering, a Science, or a related field, or a completed technical apprenticeship supplemented with relevant professional experience in a similar role.
- Knowledgeable about FDA electronic records and electronic signature requirements, as well as GAMP 5 software validation requirements.
- 2-3 years of experience in a quality assurance or operational support role within the IT sector.
- Familiarity with quality management principles and practices.
- Proficient in documentation management and process execution.
- Strong self-motivation, systematic, and analytical work ethic.
- Attention to detail.
- Excellent communication and project management skills, with a service-oriented and results-driven approach.
- General Project & Program Management skills.
- Self-starter with strong skills in creation and execution.
- Ability to troubleshoot and effectively resolve system-related issues.
- Enterprise-wide mindset – fostering productive working relationships.
- Cultural sensitivity and understanding, capable of effectively navigating international and cultural differences.
- Excellent oral and written communication skills.
- Adaptability to business strategies or changes in priorities.
- Knowledge of EN ISO 13485:2016.
- Familiarity with 21CFR Part 11 e-signature requirements.
- Awareness of IT service provider/department processes.
- Knowledge of GAMP 5 software validation.
- High proficiency in English; knowledge of German is an advantage.
- Relevant experience with Quality system IT Platforms – Trackwise, Windchill, Agile, IQVIA, etc.
- Understanding of computer software validation and assurance principles.
- Familiarity with business systems, including Windows Office, Teams, Project Place, Visio, etc.
- Basic understanding of the production of medical devices or pharmaceutical products.
- Knowledge of IT service management principles and frameworks, such as ITIL.
- Awareness of quality management standards and frameworks, including ISO 9001.
- Willingness to be on-site as required.
- Willingness to travel within Europe and the US as necessary to support projects.
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