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Senior
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0
jobs
Pharmaceutical Affairs
Kirsten Mangion
,
Sliema, Malta
Experience
Other titles
Skills
I'm offering
refer to CV
Markets
United Kingdom
Language
English
Fluently
French
Good
Italian
Good
Ready for
Available
My experience
2017 - ?
job
Pharmaceutical Affairs Manager
Lykos Pharma Ltd.
(Malta)
My current Roles and Responsibilities include:
Supporting GDP Auditor (auditing outsourced activities abroad) and assisting in the company's
Self-Inspection and Incoming Audits, participating in the on-going Quality Due-diligence, part of the Technical Agreements Action Team, participating in ongoing projects (e.g. the Implementation of Risk Management Measures Project), co-ordination with Senior Management
& other departments (e.g. logistics and administration) and handling the Daily Management of
the Quality Systems.
My current Roles and Responsibilities include:
Supporting GDP Auditor (auditing outsourced activities abroad) and assisting in the company's
Self-Inspection and Incoming Audits, participating in the on-going Quality Due-diligence, part of the Technical Agreements Action Team, participating in ongoing projects (e.g. the Implementation of Risk Management Measures Project), co-ordination with Senior Management
& other departments (e.g. logistics and administration) and handling the Daily Management of
the Quality Systems.
Administration, Risk Management, Management, Pharmaceutical, Implementation, Manager
2015 - 2017
job
Quality Systems Specialist
Arrow Pharm (Malta).
My roles and responsibilities included:
My roles and responsibilities included: training co-ordination, training personnel on GMP and the IT System, managing the SOP IT System, updating the SOPs and relevant forms, maintaining
SOPs and logbooks, compiling Annual Product Reviews and identifying any emerging trends,
actioning Change Controls (including proposals, following up on approvals, performing the required actions and closing the document), managing the CAPA system, managing CEP and
DMF updates, participating in customer complaints, assisting in client/ supplier audits and inspections and participating in current projects
My roles and responsibilities included: training co-ordination, training personnel on GMP and the IT System, managing the SOP IT System, updating the SOPs and relevant forms, maintaining
SOPs and logbooks, compiling Annual Product Reviews and identifying any emerging trends,
actioning Change Controls (including proposals, following up on approvals, performing the required actions and closing the document), managing the CAPA system, managing CEP and
DMF updates, participating in customer complaints, assisting in client/ supplier audits and inspections and participating in current projects
Training, It, Gmp, Performing, UP
2014 - 2015
job
Pharmaceutical Regulatory Affairs and Tender Officer
Cherubino Ltd.
My roles and responsibilities included:
Assisting the RP in preparing: local adaptations to variations, reviewing of SDEA, PSURs to MAHs, local adaptations of DHCPs, translation requests, updating SOPS, training employees on pharmacovigilance and GDP, ADR reconciliations, 126A applications, PI applications,
license notifications, license renewals, withdrawal of licenses, updating regulatory affairs'
databases. I was also appointed as the quality assurance personnel with regards day to day duties to fulfil GDP regulations.
I was the person responsible for the pharmaceutical tender division, identifying potential
pharmaceutical tenders or quotations, identifying suppliers or wholesalers who can supply the
product, compiling documentation, reviewing the documentation to see that the product is up to
specifications, participating in discussions held to communicate with the suppliers, preparing the online tender, reviewing the outcomes of the tenders, reviewing all pharmaceutical
contracts, updating databases relating to tendering information, preparing forecasts for the suppliers and keeping records relating to the updates in the national formulary.
Assisting the RP in preparing: local adaptations to variations, reviewing of SDEA, PSURs to MAHs, local adaptations of DHCPs, translation requests, updating SOPS, training employees on pharmacovigilance and GDP, ADR reconciliations, 126A applications, PI applications,
license notifications, license renewals, withdrawal of licenses, updating regulatory affairs'
databases. I was also appointed as the quality assurance personnel with regards day to day duties to fulfil GDP regulations.
I was the person responsible for the pharmaceutical tender division, identifying potential
pharmaceutical tenders or quotations, identifying suppliers or wholesalers who can supply the
product, compiling documentation, reviewing the documentation to see that the product is up to
specifications, participating in discussions held to communicate with the suppliers, preparing the online tender, reviewing the outcomes of the tenders, reviewing all pharmaceutical
contracts, updating databases relating to tendering information, preparing forecasts for the suppliers and keeping records relating to the updates in the national formulary.
Contracts, Training, Pharmaceutical, Quality Assurance, Regulatory Affairs, Regulatory, Pharmacovigilance, Online, Contracts, UP
My education
2015
-
2016
n/a
Masters, Pharmacy
Masters, Pharmacy
2011
-
2014
n/a
BSc, Pharmaceutical Technology
BSc, Pharmaceutical Technology
2008
-
2010
Junior College Msida
N/a, N/a
N/a, N/a
2003
-
2008
St Francis Secondary School Sliema
Masters, M.Sc. Pharmacy
Masters, M.Sc. Pharmacy
n/a
Bachelors, B.Sc. Pharmaceutical Technology (Minor in Biology, Chemistry & Marketing)
Bachelors, B.Sc. Pharmaceutical Technology (Minor in Biology, Chemistry & Marketing)
?
-
2019
n/a
MBA, N/a
MBA, N/a
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