Deskripsi Pekerjaan
Are you a meticulous and experienced Quality Control professional with a passion for ensuring the highest standards in medical manufacturing? Amaris Consulting is seeking a dedicated QC Equipment Qualification Engineer to join our dynamic team in Singapore. This is a pivotal role where you will play a crucial part in maintaining the integrity and compliance of critical equipment within a Good Manufacturing Practice (GMP) environment, directly contributing to the safety and efficacy of medical devices.
As a QC Equipment Qualification Engineer, you will be instrumental in the full lifecycle management of QC equipment, from initial qualification and validation to ongoing change control and eventual decommissioning. Your expertise will be vital in ensuring all processes adhere strictly to regulatory requirements and internal quality standards. If you thrive in a challenging yet rewarding environment where your precision and analytical skills directly impact patient outcomes, this opportunity is for you.
Join Amaris Consulting and leverage your skills to make a tangible difference in the rapidly evolving medical manufacturing landscape. We are looking for a proactive individual who is not only proficient in technical execution but also possesses excellent problem-solving abilities and a commitment to continuous improvement. If you're ready to advance your career with a global leader in innovation and technology, apply today!
Tanggung Jawab
- Lead and support the planning, execution, and documentation of QC equipment qualification activities (IQ/OQ/PQ) in accordance with GMP guidelines.
- Manage and execute change control processes for new, modified, or relocated QC equipment, ensuring all documentation is accurate and compliant.
- Coordinate and oversee the decommissioning of QC equipment, including documentation and final disposition.
- Develop, review, and approve validation protocols, reports, and associated documentation.
- Ensure all equipment qualification and validation activities comply with relevant regulatory requirements (e.g., FDA, ISO 13485) and internal quality systems.
- Collaborate effectively with cross-functional teams, including Manufacturing, Engineering, and Quality Assurance, to ensure seamless project execution.
- Provide technical expertise and guidance on equipment-related quality issues, troubleshooting, and deviation investigations.
- Maintain comprehensive and up-to-date records for all qualified equipment and related documentation within the quality management system.
Kualifikasi
- Bachelor's degree in Engineering (e.g., Biomedical, Mechanical, Electrical), Life Sciences, or a related technical field.
- Minimum of 3-5 years of experience in Quality Control, Equipment Qualification, Validation, or a similar role within a GMP medical device or pharmaceutical manufacturing environment.
- Strong understanding and practical experience with IQ/OQ/PQ protocols and execution.
- In-depth knowledge of current Good Manufacturing Practices (GMP) and relevant regulatory standards (e.g., FDA 21 CFR Part 820, ISO 13485).
- Demonstrated experience in managing change control processes for equipment.
- Excellent technical writing and documentation skills, with meticulous attention to detail.
- Proven ability to troubleshoot equipment-related issues and conduct root cause analysis.
- Strong communication, interpersonal, and problem-solving skills, with the ability to work independently and as part of a team.