QA Specialist
Abbott
Date: 3 weeks ago
City: Petaling Jaya
Contract type: Full time
Main Responsibilities
Regulatory Affairs
Education/ Experience
Regulatory Affairs
- Handle all Registration requirement of Medical Device with the Medical Device Authority (MDA)
- Liaison with appointed Comformity Assessment Body (CAB) in planning for product verification
- Liaise with local and global Regulatory Affairs personnel to ensure compliance with product registration
- On a timely basis, prepare or arrange for preparation, the Regulatory budgets, reports and forecasts
- Deliver monthly report for all regulatory activities and status report on registration to Top Management
- Provide regulatory support to all relevant Abbott Diagnostic's department in order to achieve commercial plan goal within Malaysia
- Provide timely information regarding Malaysia's legislation to management to ensure continuous Regulatory compliance
- Ensure compliance to Malaysia's Quality System as per stated in the ADD Divisional procedures and Good Distribution Practise Medical Device
- To Act as Quality Representative and facilitate both Internal and External Audits
- To carry out Post Market Survelliance and Mandatory Problem Reporting timely as per local and global requirments
- Facilitate closure of CAPA with functional owners for observation by internal and or external auditors
- Manage all local distributors as per divisional documents;Commercial Affiliate - Warehousing Storage and Distribution Processes
- Manage all Abbott Diagnoctics Purchasing and Supplier Control Processes as per stated in the divisional procedures
- Deployment of Training of Division Procedure to relevant employees to ensure guidelines are followed.
- To work functional heads, and draw up Training Plan for respective employees, and ensure timely completion of training
- Key user for SBM tools for both CAPA and Distributor Control
Education/ Experience
- Degree in Biomedicl Sciences/Bachelor in Science/Medical Laboratory Technology/Pharmacy
- Demonstrate strong attention to details and communication skills (writing/verbal) in English
- Demostrate ability to work in a multidisciplinary environment and adapt to a variety of projects/business needs
- Good Documentation Practice
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