Trainee, SiteSupport

About the Role

Responsible for impact analysis and 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

• 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.
• Facilitate the compiling of supporting documentation (e.g., 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 Investigation sub-records (e.g., F8s and F9s) and follow ups for blocking/unblocking of Product masters in SAP for GTA sites.
• Handle 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

• Proficient in MS Office tools.
• Excellent verbal and written communication skills.
• Working knowledge of a document management system.
• Ability to be flexible and multi-task in a rapidly changing environment.
• Experience of working on online modules / software would be an added advantage.

Qualifications

• Bachelor's/Master's degree in Science / Pharmacy.
• Minimum 0-1 year of experience in the Pharmaceutical industry.