PG
Proway GmbHJunior Quality Engineer
Junior Quality Engineer collaborating in project teams to maintain compliance with quality standards and regulations. Involving product validation and certification at a well - established IT company.
About the role
- Provide resource management and Quality deliverable oversight on the end-to-end Clinical Trial Process for the Clinical Quality Assurance (CQA) Process Quality and Compliance team
- Develop, implement, and execute CQA project management to support department resource management and on-time completion of tasks
- Lead regular project update meetings with CQA personnel to track CQA projects, initiatives, time requirements for tasks, and adjustments to resources
- Provide regular updates to CQA management regarding CQA resource activities and changing resource needs
- Lead project management oversight and scheduling for CQA projects separate from DU CQA support activities
- Use project management tools to design templates/tools for tracking CQA tasks and deliverables
- Support maintenance of CQA documentation, including GxP record archiving in relevant systems
- Ensure maintenance of CQA training curricula in applicable systems
- Use project management tracking tools to provide regular CQA resource utilization information to CQA management
- Provide project management oversight to non-Development Unit (DU) CQA projects and workstreams
- Facilitate unified quality audit program (UQAP) planning in CQA and act as CQA Responsible person for Investigator Site Audit (ISA) target identification and reporting
- Interface with RDQ and Development line functions for CQA resource planning related to cross-departmental initiatives
- Drive a culture of quality in Development by close business collaborating to positively impact the business and implementing RDQ Strategy, Mission and Vision
Requirements
- +7 years of involvement in regulated activities (Good Clinical Practice (GCP)/Pharmacovigilance (PV)), clinical development and/or QA positions
- 3 or more years’ experience in managing projects
- Broad understanding of global expectations of Health Authorities in Clinical Development
- Profound understanding of the science of product development
- Ability to work independently and in a global/matrix environment
- Ability to effectively interact with and present to senior management at all levels, as well as to external audiences and inspectors
- Strong skills in GCP, quality and/or clinical development
- Strong interpersonal, communication, negotiation, and problem-solving skills
- Ability to interact with and present information to management, and diverse audiences
- Skills Desired: Agility; Auditing; Audit Management; Business Partnering; Continued Learning; Drug Development; Employee Performance Evaluations; Health Authorities; Influencing Skills; ISO 9001; Leadership; Organizational Savvy; People Management; QA (Quality Assurance); Quality Management; Quality Management Systems (QMS); Risk Management; Root Cause Analysis (RCA); Self-Awareness; Stakeholder Management; Technological Expertise; Vendor Management
Benefits
- Hybrid Working (#LI-Hybrid)
- Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
- Join our Novartis Network (talent community)
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
No Education Requirement
Tech skills
Location requirements
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