inquiries, andsupport RALs in providing approved information related to API andpackaging material. Key responsibilities & Accountability : Reviews of internal document system and asses the GAP analysis asper country specific requirement.
Requests and follow up fordocuments from other stake holder departments based on GAPanalysis. Prepares the required certificates and arrange for thelegalization as per the requirements of different countries.
Preparation of the Renewal Dossiers in different formats (CTD andeCTD) as per the current guidelines of GCC and ensuring that theproduct submitted are, complete, properly formatted and comply withthe latest regulations.
Keep updating the files as per the newguidelines or the circular obtaining from different countries.Providing the status of files in the monthly report.
To updateproduct specific APQR sheets comprises of complete approvedinformation related to product at the time of dossier dispatch andupon receipts or renewal or variation approvals.
To provideapproved API supplier, packaging material details to RALs in orderto support compliance system. Qualifications : - Education Graduateof Bachelor of Pharmacy.
Technical Competencies : Proficient ComputerSkills in MS Office (Word, Excel &Powerpoint)