LOCATION:

Upper Mckinley, Taguig

JOB SUMMARY:

Assist the QA department in administering and compliance with FDA and must be knowledgeable in risk classification on drugs.

DUTIES AND RESPONSIBILITIES:

• Classifies all ADD products according to Risk Classification.
• Prepares and reviews documents for submission to FDA and NRL.
• Assists with the conduct of Performance Evaluation for DOA (Drug of Abuse), HCV, HIV, HBV, Syphilis, Anti-HBs, Anti-HBc IgM, Anti-HBc II, HBeAg, Anti-HBe and HBsAg Confirmatory tests.
• Create letter to notify FDA for the amendment of documents regulated products.
• Follow up with NRL for the endorsement of FDA for the conduct of Performance reports of Performance evaluation.
• Check FDA website for the status of regulated products for Certificate of Registration.
• Follow up FDA for the release of Certificate of registration of regulated products.
• Review and file all authenticated documents.
• Comply to Quality and Regulatory document requirements.
• Update the regulatory information system on valid Certificate of Exemption and Certificate of Product registration.
• Organize files.
• Perform other duties as assigned.