Serialisation Data Analyst - 6 month FTC
Accountable for the effective identification, investigation and resolution of alerts from scanned pharmaceutical product primarily across 28 European countries. Issues and queries relating to the decommissioning of serialised packs at any point in the supply chain.
KEY RESPONSIBILITIES & ACCOUNTABILITIES:
1. Monitor incoming daily alerts in Tracelink via European wide system (EUHub) which come from national verification systems.
2. Manage Issues and queries on a daily basis related to serialised product which arise from manufacturing sites, Contract Manufacturers (CMO's), 3PL's/distributors, marketplace (Regulatory/Quality), Pharmacies and/or National authorities
3. Gather and record all available information immediately available from direct access to related data and deduce resolution and fixes.
4. Assess if there is enough info available to make judgement on cause of alert. If not, contact SMEs in order to obtain required information and update Alert details
5. Triage on alert at high level to decide how to progress and fix
6. Manage and co-ordination of resolution of alerts through to completion
7. Raise and follow up on CAPA as an outcome of an issue/alert/query
8. Keep a record of all actions, decisions and progress for all alerts
9. Maintain up to date metrics on all alerts
10. Report on status of alert resolution at relevant management meetings (weekly/monthly reporting)
11. Assist in the design and implementation of the long-term process to manage alerts from any source (IT systems, distributor, CMO, site, market)
12. Support the Master Data Team with data updates when relevant
13. Attend regular webinars hosted by serialisation suppliers and national medicines organisations on latest trends in changes in track and trace/serialisation landscape.
14. Role initially may be a secondment or fixed term contract, with intention to make the role permanent as the new serialisation/track and trace function becomes embedded in the organisation.
Work with following internal departments: Global IT, Regulatory Affairs, Data Management, Artwork, External Network Supply Chain and Quality, Quality at manufacturing sites
External interactions: Tracelink (IT system supplier), European Medicines Verification Organisation (EMVO), various National Medicines Verification Organisations (NMVO's), Distributors/wholesalers.
SKILLS & KNOWLEDGE
· Quick learner, able to use multiple IT systems with minimum guidance
· Trouble-shooter with tenacity to see issues through
· Proficient in data analysis and reporting, using pivot tables and VLOOKUP's in Excel or similar data/BI tools
· Able to work on own initiative
· Advanced problem-solving skills such as researching into new areas
· Methodical/ logical thinker
· Clear communicator, written and verbally
· Able to multitask
· Able to document processes and improvements
· Proficient user in other MS Office tools (PowerPoint, Word and Project)
-Overview of serialisation or track and trace in the pharmaceutical industry, in particular EUFMD (European Falsified Medicines Directive)
Good knowledge of working with IT systems within Norgine such as E1, LIMS, VEEVA
Understanding of Norgine's product portfolio
Systems and knowledge to be gained as part of the role includes:
· Tracelink - to view Products/ Serialisation data from manufacturing sites and CMO's, Reporting serialisation data to EU Hub and NMVS
· Optel/OSM - to view batch reports related to Lots/Serial Codes
· JD Edwards EnterpriseOne - To view Lot status for products
· End to end Serialisation process from manufacturer to EU Hub and NMVS (National Medicines Verification Systems)
· EU FMD regulations and master data requirements
· Global Standards GS1: Global Trade Item Numbers (GTIN's), Global Location Numbers (GLN's), Global Company Prefix (GCP's)