Master Data Specialist

Job Description:

PURPOSE of the assignment:

• Management of specifications and original documents
• Management of Quality Master Data

RESPONSIBILITIES

1. Management of specifications in ETQ ASM
2. Drafting, updating, approving, and archiving of:
3. Heist Goods Receipt Slips (HGRS)
4. Heist Supplier Material Specifications (HSMS)
5. Compliance with pharmacopoeias: independently decide, monitor, and coordinate implementation of updates
6. Initiate, review, assess impact, and approve change requests in ETQ; timely execution of change tasks
7. Management of statements: TSE/BSE, residual solvents, allergens, etc.
8. Preparing statements for GRA, Global CMC, registration purposes
9. Preparing certificates for reworks, registration purposes
10. Reviewing and approving:
11. Lab Data Sheets (LDS) and Heist Approved Supply Chains (HASC) in ETQ
12. GLIMS configuration via e-requests
13. AP configuration via ECOs, eLogs, Appians, and MDG
14. Concurrence on MDG change requests from other sites
15. Compliance with registered information:
16. handling ORION and RELIANT notifications
17. keeping specs and test methods, actives, and changed processes up to date
18. requesting registration info and status
19. Management and changes to Quality Master Data in SAP for code creations and extensions, including initiating change requests, eLogs, and MDG change requests for:
20. Shelf life, Expiry Date Format, rounding rules
21. Storage conditions in Label Data
22. Registered Country Table (RCT)
23. Licenses in GTS
24. Other QM-related fields
25. Creating and modifying QIRs (Quality Info Records) in SAP
26. Creating, modifying, approving, and archiving Coding Notices for finished products and bulk products based on code creations and extensions, ETQ change management, etc.
27. Setting up RCT/GTS based on destination control forms
28. Management of Material Control in SAP
29. Management of Positive Lists for each IPT
30. Management of SOPs for the department
31. Participation in or leadership of specific projects
32. Challenging existing concepts and proposing optimizations
33. Representing the team internally and externally

RELATIONSHIPS

Internal:

• Contact with:
• SAP and ORGLIMS configurators
• Local MDM team
• Compliance and Purchasing (mainly for approved suppliers, Technical Agreements)
• Production departments
• QO (mainly for ETQ ASM, compendia, LDSs)
• Plant Quality (mainly for change requests and deviations)
• Logistics/Planning (mainly Coding Notices)
• PTO (mainly for new product projects)
• Team collaboration within the department (necessary for proper follow-up)

External:

• Contact with:
• Other Organon sites + Global groups (Compendia, AS)
• MSD (via CMO team)
• Global CMC + GRA (Global Regulatory Affairs; regarding shelf life, registration dossiers, permits/declarations) + FAMHP (Federal Agency for Medicines and Health Products)
• Regional/Global Demand Fulfillment/Order Management (destination control)
• Suppliers for requesting certificates/statements: TSE-BSE, residual solvents, allergens, etc.
• Global/regional MDM

Required skills for this assignment:

Education: University degree or equivalent (industrial pharmacist, bioengineer, (bio)chemical engineer, master's in (bio)chemistry, biomedical sciences, etc.)

Experience: Experience with pharmacopoeias, lifecycle document management, and project work is a plus

Technical skills:

• PC proficiency required: MS Office package (Word, Excel, PowerPoint, (Access
• Analytical mindset
• Organizational skills
• Smooth administrative handling and control
• Fluent in English (speaking and writing)

Personal traits:

• Sense of responsibility
• Perseverance
• Accuracy
• Interest in quality
• Able to work independently and as part of a team
• Comfortable with administrative work
• Leadership qualities