Eman Mardini Email & Phone Number

Jordan

Amman, Jordan

Amman Jordan

Build quality system according to Good Distribution Practices (GDP) , Good Storage Practices (GSP) guidelines & ISO 9001;2015Ensure quality management system (QMS) & related procedures are available, communicated & implemented.Certified lead auditor ISO9001:2015 / unique delegate no. 15530 in the international register of certified auditors / LondonCertified internal auditor ISO9001:2015 & Good Distribution Practices (GDP)Business development assistant: IMS… Show more Build quality system according to Good Distribution Practices (GDP) , Good Storage Practices (GSP) guidelines & ISO 9001;2015Ensure quality management system (QMS) & related procedures are available, communicated & implemented.Certified lead auditor ISO9001:2015 / unique delegate no. 15530 in the international register of certified auditors / LondonCertified internal auditor ISO9001:2015 & Good Distribution Practices (GDP)Business development assistant: IMS analysis, registration requirements & products classification., imports data & tenders details Market study: market need, sales figures, marketing, pharmaceutical & regulatory challenges.Responsible for product release to market Recall: compel recall when needed & conduct mock recall regularly with sales teamInventory management: inventory count, near exp. goods follow up, official destruction...etc.Training: annual plan, training needs, training reports, records & evaluation.Maintain and monitor third-party suppliers’ performanceEnsure qualification & calibration processes are conducted on time & according to requirementsReport customer complaints in accordance with global and local requirementsInternal accidents: management, investigation, reporting & documentation.Change control and risk assessment Show less

Amman- Jordan

QA Job Responsibilities:• Build quality system according to Good Distribution Practices (GDP) , Good Storage Practices (GSP) guidelines & ISO 9001;2015• Ensure quality management system (QMS) & related procedures are available, communicated & implemented.• Responsible for product release to market • Recall: compel recall when needed & conduct mock recall regularly with sales team• Inventory management: inventory count, near exp. goods follow up, official… Show more QA Job Responsibilities:• Build quality system according to Good Distribution Practices (GDP) , Good Storage Practices (GSP) guidelines & ISO 9001;2015• Ensure quality management system (QMS) & related procedures are available, communicated & implemented.• Responsible for product release to market • Recall: compel recall when needed & conduct mock recall regularly with sales team• Inventory management: inventory count, near exp. goods follow up, official destruction...etc.• Training: annual plan, training needs, training reports, records & evaluation.• Maintain and monitor third-party suppliers’ performance• Ensure qualification & calibration processes are conducted on time & according to requirements• Report customer complaints in accordance with global and local requirements• Internal accidents: management, investigation, reporting & documentation.• Change control and risk assessmentExperience – as regulatory affairs officer: •Submit registration files to JFDA (company registration file, registration files for pharmaceutical products, medical devices, vitamins & food supplements)•Compel & submit renewal files & post approval changes (PAC) to JFDA•Products’ classification•Follow up with QC lab at JFDA: validation committee, R&D & routine analysis.•Communicate JFDA requirements to partners / suppliers.•Prepare market study about registered products in Jordanian market.•Backup for drug safety officer / Pharmacovigilance. Show less

Mubes - Jordan

•Follow up regulatory tasks for local & export markets (i.e. KSA, UAE ...etc).•Submit registration files for pharmaceutical products to JFDA, SFDA & UAE.•Follow-up with health authorities & agents to ensure timely submission of registration files, renewals, PAC & additionally requested documents.