Project Quality Management Expert (English, CSV, GxP, IT)

D-ploy, a leading IT and Engineering Solutions company with operations throughout the EMEA region and the USA, is seeking a Project Quality Management Expert to join their team. As a member of the D-ploy team, the Project Quality Management Expert will be responsible for ensuring that project deliverables meet the highest standards of quality and compliance. The successful candidate will work with cross-functional teams to identify project risks and implement strategies to mitigate those risks. They will also be responsible for developing and implementing project quality management plans to ensure compliance with industry standards and best practices.

D-ploy prides itself on delivering innovative and superior services and solutions to numerous industry-leading clients. By building relationships and trusted partnerships within the IT community, D-ploy optimizes their customer's IT productivity and contributes to the organization's success and value. If you are an engaging, flexible, and solution-oriented individual looking to become part of a dynamically growing and international organization, D-ploy is the place for you.

Responsibilities

• Ensure that project deliverables meet the highest standards of quality and compliance
• Collaborate with cross-functional teams to identify project risks and implement strategies to mitigate those risks
• Develop and implement project quality management plans to ensure compliance with industry standards and best practices
• Manage quality and compliance activities in project plan
• Monitor project progress and identify areas for improvement
• Analyze project data to identify trends and opportunities for improvement
• Ensure compliance with regulatory and legal requirements

• Prepare for and lead meetings
• Manage quality and compliance activities in project plan
• Manage quality (quality reviews, stakeholders)
• Develop quality / validation plan
• Lead risk-based approach to validation (Functional Risk Assessment, Computer Software Assurance)
• Develop quality / validation report
• Develop and deliver project quality management training to project teams
• Get trained on applicable policies and processes
• Train and coach project team on quality (GxP, CSV, SLC processes, etc.)
• Train project team on testing and on using test tools.
• Define required system life-cycle documentation.
• Manage system life-cycle documentation in repositories.
• Review user requirements, traceability, tests and test results
• Testing: Test strategy / plan, manage testing (planning, execution, defect management, reporting), write Test report

• Proven experience as a Project Quality Management Expert (min. 4 years)
• Strong knowledge of project management methodologies and best practices
• Experience with GxP, CSV, GAMP (min. 4 years)
• Good understanding of pharmaceutical validation requirements driven by health authorities
• Software Development Methodologies: Agile, Dev/SecOPs (desired)
• Excellent analytical and problem-solving skills
• Strong communication and interpersonal skills
• Ability to work effectively in a cross-functional team environment
• Experience working in the IT industry
• Bachelor's degree in IT, Engineering, or a related field (or equivalent experience)
• Fluency in English
• Candidates have to declare Criminal record extract not older than three months

• Broad range of activities, tasks, and projects
• Flexible working conditions
• Fishing for Friends program – our referral program
• Further development and professional advancement
• Friendly and international working environment
• Competitive salary and various benefits

Is IT in your DNA?