✨ About The Role
- The Quality Assurance Specialist will be responsible for ensuring compliance with internal SOPs and external regulatory requirements.
- The role involves managing quality and regulatory documentation, including risk management files and procedural documents.
- Conducting risk assessments to support product safety and quality is a key responsibility.
- The specialist will lead and manage Corrective and Preventive Actions (CAPA) to ensure timely resolutions.
- Complaint handling and regulatory reporting will be overseen by the specialist, ensuring accurate and timely investigations.
- The role requires collaboration with cross-functional teams to maintain product quality and regulatory compliance.
⚡ Requirements
- The ideal candidate will have 2-3 years of hands-on experience in regulated quality systems and product manufacturing.
- A background in medical device or pharmaceutical quality systems is preferred for this role.
- Strong analytical skills are essential for analyzing data and processes to recommend improvements.
- The candidate should be able to learn and stay updated on industry regulations and standards.
- Attention to detail and the ability to prioritize tasks effectively are crucial for success in this position.
- Excellent technical writing and verbal communication skills are necessary for effective collaboration and documentation.