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Quality Assurance Manager
2 months ago
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 improvement of quality processes, with a focus on validation and software-related procedures.
- Manage CAPA Processes: Oversee the management of Corrective and Preventive Action processes related to validation and software quality issues.
- Document Management: Ensure the accuracy, accessibility, and compliance of relevant documents with regulatory standards.
- 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 System Management: Ensure that quality systems across the AMS Group, with an emphasis on software-related processes, comply with applicable GAMP, cGMP, MDSAP, and Medical Device Regulation (MDR).
- 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.
