Quality Operations Search Specialist
4 hours ago
Job Summary
">As a Search Specialist in Quality Operation, you will be responsible for handling customer complaints, field alerts, recalls, and conducting investigations. You will independently handle meetings with business partners and create Quality assurance agreements and Quality risk assessments.
">Key Responsibilities">- ">
- Handling of customer complaints, field alerts, recalls, and conducting investigations.">
- Creating Quality assurance agreements and Quality risk assessments.">
- Understanding of Audits & CAPA management for suppliers.">
- Strong understanding of Quality Management System and GxP requirements.">
Supporting the Team
">You will provide support in preparation, review, and approval of GMP documents including local and global SOPs, WP s, Investigation reports, etc. where required. You will ensure implementation of applicable QMS requirements in the function and provide timely and effective communication of any potential compliance gaps/risks in respective function.
">Additional Responsibilities
">You will initiate, monitor, and fulfill the timely review of APQR documents for all own site and Contract manufacturers. Additionally, you will provide quality support to Nitrosamine risk-based evaluation/Changes and initiate and implement quality improvement/simplification projects, wherever possible.
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