Trainee, SiteSupport

Apotex; Mumbai; On-site; INR 300,000 - 500,000; Full time

Job summary

VELNEXAA TECHNOLOGIES LLP in Mumbai seeks a Document Specialist for impact analysis and Master Production/Packaging documentation management. You will handle MPPDs and material masters, coordinating with cross-functional teams to ensure accuracy and compliance.

You will support change controls, compile documentation, and ensure alignment with cGMP and SOPs while mentoring teams and maintaining strong stakeholder relationships.

Qualifications

• Bachelor's or Master's degree in Science or Pharmacy.
• Proficient in MS Office tools.
• Excellent verbal and written communication skills.
• Experience with document management systems would be an advantage.
• 0–1 year of pharmaceutical industry experience.

Responsibilities

• Create, review, execute, and cancel Master Production and Packaging Documents (MPPD) and Master data for GTA sites.
• Collaborate with Quality to perform impact analysis for change control packages.
• Compile supporting documentation (mark-ups, reports).
• Ensure changes align with cGMP and corporate SOPs.
• Manage investigation sub-records (F8s/F9s) and related SAP activities for GTA sites.

Skills

MS Office tools

Communication skills

Document management

Education

Bachelor's/Master's degree in Science/Pharmacy

Tools

Document management system

Job description

Job Summary

• Responsible for impact analysis/handling of Master Manufacturing and Packaging records (MPPDs).
• Responsible to escalation of 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.