Project Lead Quality Assurance Specialist

4 days ago

Winsford, Cheshire, United Kingdom Advanced Medical Solutions Full time
About the Role

We are seeking a highly skilled Project Lead Quality Assurance Specialist to join our team at Advanced Medical Solutions. As a key member of our Group Quality Process Team, you will play a critical role in delivering our Quality Assurance Strategy and ensuring compliance with regulatory requirements.

Key Responsibilities
  • Lead Validation Activities: Oversee the validation of new software systems to ensure alignment with regulatory requirements.
  • Collaborate with Cross-Functional Teams: Work closely with various teams to implement new systems while maintaining quality standards.
  • Continuous Improvement: Drive the continuous improvement of quality processes, with a focus on validation and software-related procedures.
  • Manage CAPA Processes: Oversee Corrective and Preventive Action processes related to validation and software quality issues.
  • Document Management: Ensure accuracy, accessibility, and compliance with regulatory standards for relevant documents.
  • Project Management: Contribute to the development and execution of project management activities, with a focus on software projects.
  • Audit and Compliance: Collaborate with audit stakeholders to identify areas for improvement and facilitate corrective actions.
  • Quality Systems: Ensure quality systems across the AMS Group comply with applicable regulations, including GAMP, cGMP, MDSAP, and Medical Device Regulation (MDR).
Requirements
  • Education: Bachelor's degree or equivalent in a scientific discipline or comparable experience in the medical device or pharmaceutical industries.
  • Experience: At least 2 years of experience in the medical device or pharmaceutical industries.
  • Skills: Proficiency in applicable Quality System Regulations, ISO quality requirements, and specific regulations like GAMP, 21 CFR Part 11, and Eudralex.
  • Communication: Strong written and oral communication and presentation skills for effective communication with staff, peer groups, etc., across the organisation.
  • Technical Skills: Proficiency in Word, Excel, and PowerPoint for documentation and presentation.
  • Time Management: Effective time management, task prioritisation, and the ability to meet critical deadlines while supporting multiple projects.

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