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

Job Summary

• 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.

Job 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 but not limited to the following:
  • 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. 
• To 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.
• Working in partnership with teams of highly experienced individual contributors to execute and deliver project results by leveraging expertise in mentoring, relationship building, strategic thinking and team building.
• Develop and manage working relationships with Business Stakeholders to assess their needs, determine customer service levels and manage service delivery, becoming a trusted strategic partner.
• 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.
• Demonstrate Behaviours that exhibit our organizational Values: Integrity, Teamwork, Courage, and Innovation.
• 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.

Job Requirements

• Education
  • Bachelor’s/ Master’s degree in Science / Pharmacy
    
    
• Knowledge, Skills and Abilities
  • Should be proficient in MS office tools.
  • Should have excellent verbal & written communication skills.
  • Experience of working on online modules / software would be an added advantage.
  • Working knowledge of a document management system required.
  • Ability to be flexible and multi-task in a rapidly changing environment.
    
    
• Experience
  • Minimum 0-1 year of experience in the Pharmaceutical industry.