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Labelling Change Control Specialist EMEA Emerging Markets
Requisition ID: 1705615264W
EMEA Emerging Markets Regulatory Affairs intends to recruit a Labelling Change Control Specialist, based in Cairo due to introduction of a new Governance model for Label Management in Middle and Near East countries as well as Sub-Saharan African countries of Ghana, Kenya and Nigeria. In EMEA Emerging Markets dependency on CCDS update has been replaced by reliance on reference approval for local labels. A shared multicounty pack is being created for each product. This demands careful management of business compliance tools like Track wise /Integras for countries sharing multicounty packs. Any locally driven changes to multicountry pack should be documented in Track Wise compliance tool and Track Wise ID must form the basis of any outer and immediate packaging artwork amendment. This is a temporary administrative role and available for 1 year duration.
You will be working within EMEA Emerging Markets Regulatory and reporting into EMEA Emerging Markets Labelling & Supply Chain Managerto support on-time Trackwise ID creation and database update for products licenced across Middle and Near East and Sub-Saharan African countries of Ghana, Kenya and Nigeria. Your main tasks will include:
- Becoming Track Wise super user for the region indicated above
- involving business compliance for guidance when appropriate. Ensuring local operating companies remain compliant at all times when any locally driven changes demand update of artwork
- Uploading SC plan into Track Wise as appropriate.
- Supporting Labeling Specialist during peak period of activity in administrative tasks
- responsible person has submitted the confirmation letter upon regulatory approval to manufacturing plant to avoid any inclusion of unapproved packaging components.
- supply chain personnel are informed of all upcoming regulatory activities which may result in packaging or leaflet update.
- effective and expeditious communication on destruction of stock with out of date labelling components.
Previous experience and skills:
You must possess following experiences and skill sets in order to apply for this position:
· Attention to details, deadlines and administration
· Good oral & written communication skills in English
· Agility to work with people from different cultural, economic and political backgrounds
Janssen Cilag Ltd. (7360)