Job Description:
PURPOSE of the assignment:
* Management of specifications and original documents
* Management of Quality Master Data
RESPONSIBILITIES
* Management of specifications in ETQ ASM
* Drafting, updating, approving, and archiving of:
* Heist Goods Receipt Slips (HGRS)
* Heist Supplier Material Specifications (HSMS)
* Compliance with pharmacopoeias: independently decide, monitor, and coordinate implementation of updates
* Initiate, review, assess impact, and approve change requests in ETQ; timely execution of change tasks
* Management of statements: TSE/BSE, residual solvents, allergens, etc.
* Preparing statements for GRA, Global CMC, registration purposes
* Preparing certificates for reworks, registration purposes
* Reviewing and approving:
* Lab Data Sheets (LDS) and Heist Approved Supply Chains (HASC) in ETQ
* GLIMS configuration via e-requests
* AP configuration via ECOs, eLogs, Appians, and MDG
* Concurrence on MDG change requests from other sites
* Compliance with registered information:
* handling ORION and RELIANT notifications
* keeping specs and test methods, actives, and changed processes up to date
* requesting registration info and status
* Management and changes to Quality Master Data in SAP for code creations and extensions, including initiating change requests, eLogs, and MDG change requests for:
* Shelf life, Expiry Date Format, rounding rules
* Storage conditions in Label Data
* Registered Country Table (RCT)
* Licenses in GTS
* Other QM-related fields
* Creating and modifying QIRs (Quality Info Records) in SAP
* Creating, modifying, approving, and archiving Coding Notices for finished products and bulk products based on code creations and extensions, ETQ change management, etc.
* Setting up RCT/GTS based on destination control forms
* Management of Material Control in SAP
* Management of Positive Lists for each IPT
* Management of SOPs for the department
* Participation in or leadership of specific projects
* Challenging existing concepts and proposing optimizations
* 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