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Implementation Project Lead

1 month ago

Winsford, Cheshire, United Kingdom Advanced Medical Solutions Full time
Job Title: Implementation Project Lead

Advanced Medical Solutions is seeking a highly skilled Implementation Project Lead to support the Group Quality Process Team in delivering the Quality Assurance Strategy. As a key member of the team, you will be responsible for ensuring compliance with regulatory requirements through the effective implementation and continuous improvement of the Quality Management System (QMS), with a specific focus on software validation.

Key Responsibilities:

  • Lead validation activities for new software systems, ensuring alignment with regulatory requirements.
  • 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.
  • Ensure quality systems across the AMS Group comply with applicable GAMP, cGMP, MDSAP, and Medical Device Regulation (MDR).

Requirements:

  • BS or equivalent in 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.
  • 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.

What We Offer:

Advanced Medical Solutions offers a dynamic and challenging work environment, with opportunities for professional growth and development. As a valued member of our team, you will have access to a range of benefits, including competitive salary, comprehensive training, and opportunities for career advancement.