Trainee, GBS-AGO-SiteSupport-GBS-AGOSS G

About the Role

Responsible for impact analysis/handling of Master Manufacturing and Packaging records (MPPDs). Responsible to escalate any critical issues arising during working on MMaR, MPaR, and Change Controls.

Key Responsibilities

• Responsible for Creation/Review/Execution/Cancellation for Master Production and Packaging Documents (MPPD) and Material Masters and Master recipes for GTA sites.
• Collaborate with cross functional teams and Quality to perform a thorough and complete impact analysis for the change control package, including:
• Facilitate the compiling of supporting documentation (i.e. Mark-ups, reports).
• Ensure all related documents and data affected by a change request are captured.
• Ensure changes outlined in the change management system coincide with mark-ups and/or proposed change.
• Generate and manage the Investigation sub-records (i.e. F8s and F9s) and follow ups for blocking/unblocking of Product masters in SAP for GTA sites.
• Responsible for handling of Weekly and Monthly reports / Initiate TO Project Acceptance Approval Form/ F8- Bulk M2M/Readiness-Lighthouse for GTA sites as needed.
• Ensure all changes are aligned with cGMP regulations and corporate SODs.
• Serve as a technical resource to internal/external customers and key stakeholders in the development of Master Production & Packaging documentation.
• Provide support for the interpretation and incorporation of recommendations coming from Validation and Technical Operations for the updating of commercial master documentation.
• Review the accuracy of all manufacturing instructions imported into master documents during detailed Impact Analysis as listed in the scope of the change request.
• Develop and manage working relationships with Business Stakeholders to assess their needs, determine customer service levels and manage service delivery.
• Facilitate cross-functional discussions ensuring all items and issues have been resolved and/or escalated to the appropriate individuals in the interest of Manufacturing Support.
• Report anomalies and communicate any changes required for correcting discrepancies found in all Master Production and Packaging Documents.
• Develop and revise Standard Operating Documents governing and relating to Manufacturing Support functions as required.
• Ensure compliance with current Standard Operating Procedures and Work Instructions related to Document Specialist activities and report errors and inconsistencies associated with approved procedures to the People leader.
• Develop and maintain effective working relationships with internal and external customers.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Requirements & Tech Stack

• MS Office proficiency.
• Working knowledge of a document management system.
• SAP
• cGMP
• SODs

Qualifications

• Bachelor’s/ Master’s degree in Science / Pharmacy.
• Excellent verbal & written communication skills.
• Ability to be flexible and multi-task in a rapidly changing environment.
• Experience of working on online modules / software would be an added advantage.