Job Ref. ID:
Trainee / Intern
UNITED ARAB EMIRATES
UAE (RAK head office)
Full Time Employment (Un-limited Contract)
The Trainee / Intern will be responsible for the variation and renewal of file preparations, GAP Analysis for registered products and follow ups, review for API vendor lists and providing status of variation files, maintain compliance of dossier as per current regulation, respond to Health Authorities' inquiries, and support RALs in providing approved information related to API and packaging material.
Key responsibilities & Accountability:
Reviews of internal document system and asses the GAP analysis as per country specific requirement.
Requests and follow up for documents from other stake holder departments based on GAP analysis.
Prepares the required certificates and arrange for the legalization as per the requirements of different countries.
Preparation of the Renewal Dossiers in different formats (CTD and eCTD) as per the current guidelines of GCC and ensuring that the product submitted are, complete, properly formatted and comply with the latest regulations.
Keep updating the files as per the new guidelines or the circular obtaining from different countries.
Providing the status of files in the monthly report.
To update product specific APQR sheets comprises of complete approved information related to product at the time of dossier dispatch and upon receipts or renewal or variation approvals.
To provide approved API supplier, packaging material details to RALs in order to support compliance system.
Graduate of Bachelor of Pharmacy.
Fresh Graduate or at least 1 year of experience.
Can work independently with less supervision
Excellent verbal and written communication skills.
Proficient Computer Skills in MS Office (Word, Excel & Powerpoint)
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