Technology Innovation Project Manager
2 months ago
Group Quality Project Lead
Advanced Medical Solutions is a world-leading developer and manufacturer of innovative tissue-healing technology, focused on quality outcomes for patients and value for payers. We are seeking a highly skilled Quality Assurance Strategist to support the Group Quality Process Team in delivering the Quality Assurance Strategy, aligning with corporate goals and objectives.
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).
- Lead the development and improvement of the quality management system across the AMS Group with a focus on software validation.
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.
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Winsford, Cheshire, United Kingdom Advanced Medical Solutions Full time{"h1":{"text":"Job Title: Implementation Project Lead"}},Job SummaryAdvanced Medical Solutions is seeking an experienced Implementation Project Lead to support the Group Quality Process Team in delivering the Quality Assurance Strategy. The successful candidate will ensure compliance with regulatory requirements through the effective implementation and...
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