Quality System and Regulatory Specialist

Job title:

Quality System and Regulatory Specialist

Company

D-ploy

Job description

D-ploy is an IT and Engineering Solutions company with operations throughout the EMEA region including Switzerland, Germany, Czech Republic, Austria, UK, as well as the USA.We pride ourselves on delivering innovative and superior services and solutions to numerous industry-leading clients. By building relationships and trusted partnerships within the IT community, we optimize our customer‘s IT productivity and contribute to the organization’s success and value.We are interested in talking to engaging, flexible, and solution-oriented individuals who are looking to become a part of a dynamically growing and international organization. We are focused on creating value where IT counts, join us!Role OverviewThe Quality System and Regulatory Specialist is responsible for ensuring compliance with industry standards and regulatory requirements. This role oversees quality management systems, audits, and regulatory processes, collaborating with internal teams and external stakeholders to maintain ISO 9001, ISO 27001, and GxP compliance. It includes managing quality tools, CAPA processes, and continuous improvement initiatives to enhance operational efficiency and regulatory adherence.ResponsibilitiesCross-functional Collaboration

• Work closely with internal and external stakeholders to ensure compliance with industry standards and regulatory requirements.

Quality & Regulatory Systems Management

• Oversee quality management systems and regulatory processes, ensuring validated status and compliance.
• Manage supplier lifecycle and training requirements related to regulatory policies.

Tool Management & Validation

• Define and execute system validation processes for quality and compliance tools.

Audit & Compliance

• Conduct internal audits and ensure compliance with ISO 9001, ISO 27001, and GxP standards.
• Manage external inspections and facilitate customer audits.
• Handle regulatory and security questionnaires.

CAPA Management

• Oversee the Corrective and Preventive Actions (CAPA) lifecycle, including deviations and audit findings.

Process Improvement

• Drive continuous improvement initiatives to enhance quality, compliance, and regulatory processes.

Requirements

• Experience in quality management, CAPA lifecycle, and system validation.
• Strong knowledge of ISO 9001, ISO 27001, and GxP regulations.
• Hands-on experience in internal and external audits (customers or certification bodies).
• Familiarity with computer system validation in regulated industries.
• Understanding of the software development lifecycle and agile methodologies (Scrum preferred).
• Experience with document control systems such as TrackWise or Salesforce.
• Fluent in English; additional languages are a plus.
• Candidates must declare Criminal record extract not older than three months.

Preferred Qualifications

• Experience working with SaaS products in regulated environments.

Additional Information

• Travel may be required within Europe and the US (up to 5%).

Benefits

• Broad range of activities, tasks, and projects
• Fishing for Friends program – our referral program
• Further development and professional advancement
• Friendly and international working environment
• Company-sponsored events

Is IT in your DNA?

Expected salary

Location

Woking, Surrey

Job date

Thu, 27 Feb 2025 23:33:59 GMT

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