Data Administrator CMC Documentation Job Details | Bayer AG

Data Administrator CMC Documentation

PURPOSE

The data administration team, CMCD Consumer Health, manages the scientific and regulatory data associated with all Bayer Consumer Health (BHC) Formulations, and maintains BCH data in an up-to-date state.

The team exemplifies the CMCD operating principles:

• Best for Bayer - Maximise and Return on Investment
• Right Work, Right Way, Right Time - Standardisation of process
• Clear Roles, Responsibilities and Terminology - Globally visible definitions
• Universal Global Approach - Applicable across all consumer health
• Centralised Accountability - Single point of Module 3 ownership cradle to grave
• Knowledge, Change and Risk Management - Aligned with Global Quality Systems

MAJOR TASKS

• Manage scientific and regulatory data associated with BCH Formulations as defined by SOP.
• Single point of receipt for all sources of change that may impact BCH Formulations.
• Triage changes received, compile data, assess relevance, and funnel to SMEs for review.
• Use BCH Change Control tools to manage change implementation.
• Manage and update data in the BCH data management systems to ensure up-to-date state.
• Provide service to BCH globally to facilitate rapid turnaround and ensure no manufacturing downtime.
• Coordinate SMEs to deliver on-time impact assessments and implementation plans.
• Post creation, own the data for the lifetime of the Formulations.
• Create and manage tools for continuous improvement and efficiency.
• Coordinate closely with Procurement in effective data gathering, communicate effectively with suppliers and manufacturers.
• Manage effective and efficient data flow between customers and stakeholders.
• Responsibility covers all global and local markets.
• Effectively communicate risk through correct channels, proposing appropriate mitigation strategies.
• Build a solid foundation of trust throughout the wide BCH business.

WHO YOU ARE

• Experienced in data management.
• Experienced in project management.
• Experienced in IT systems and data integrity.
• Working knowledge of Pharmaceutical/Consumer Health industry regulations.

The Data Administrator CMC Documentation requires appropriate education in Lifesciences, preferably Chemistry and/or relevant experience in the field.

Application Period: 11/08/2024 - 11/18/2024

Reference Code: 833479

Division: Consumer Health

Location: Indonesia : West Java : Cimanggis

Functional Area: Quality

Position Grade: R12

Employment Type: Regular

Work Time: Standard working hours

Contact Us

Email: ronwilfred.lee@bayer.com