Project Lead Quality Assurance Specialist

7 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 for new software systems, ensuring alignment with regulatory requirements such as GAMP, cGMP, MDSAP, and Medical Device Regulation (MDR).
  • Collaborate with cross-functional teams to support the implementation of new systems while ensuring compliance with quality standards.
  • Oversee continuous improvement of quality processes, with a specific focus on validation and software-related procedures.
  • Manage Corrective and Preventive Action (CAPA) processes related to validation and software quality issues.
  • Drive document management processes, particularly those related to software validation documentation.
  • Ensure accuracy, accessibility, and compliance with regulatory standards for all relevant documents.
  • Contribute to the development and execution of project management activities, with a particular focus on software projects.
  • Collaborate with audit stakeholders to identify areas for improvement and facilitate corrective actions.
  • Ensure quality systems across the AMS Group, with an emphasis on software-related processes, comply with applicable regulations.
  • Lead the development and improvement of the quality management system across the AMS Group with a focus on software validation.
  • This is a remote position, with 15% travel to sites expected when required.
Requirements
  • BS or equivalent in a scientific discipline or comparable experience in the medical device or pharmaceutical industries.
  • At least 2 years of experience in medical device or pharmaceutical industries.
  • Proficiency in applicable Quality System Regulations, ISO quality requirements, and specific regulations like GAMP, 21 CFR Part 11, and Eudralex.
  • Ability to develop and implement quality improvement initiatives, including tracking, analysing, and reporting on progress and effectiveness.
  • Strong written and oral communication and presentation skills for effective communication with staff, peer groups, etc., across the organisation.
  • Proficiency in Word, Excel, and PowerPoint for documentation and presentation.
  • Effective time management, task prioritisation, and the ability to meet critical deadlines while supporting multiple projects.

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