Job Summary

- Responsible for creating and/or making formatting changes and edits to draft documents based on supporting documentation from Business Units (i.e.

Technical

Transfer packages

- Technical Operations Reports, Validation Reports) for Apotex.

- Responsible to escalate any critical issues arising from the MMaR / MPaR while

- Responsible for working on POMS

- Responsible to Support Manufacturing Execution System

- Responsible for Primary Technical Writer role for change control process in creation and review of MMaR and MPaR for Signet and Etobicoke sites.

Job Responsibilities

- Creating and/or making formatting changes and edits to draft documents based on supporting documentation from Business Units (i.e.

Technical

Transfer packages

- Technical Operations Reports, Validation Reports).

- Migration of MPPDs into new MMaR &

- MPaR

- Working on MMaR execution in POMS

- Working with Vendor and GTA to Support Manufacturing Execution System project in Design, Configuration and Master Data processes.

- Execution and Cancellation of documents in Content

- Creation and peer review of MDoc s for Cancellation CCR s.

- Drafting and review of MMaRs and MPaRs for Richmond Hill

- Responsible for Primary Technical Writer role for change control process for cancellation of documents for Signet and Etobicoke sites.

- Working on creation of Change Control Records for Packaging Material codes cancellation for Richmond Hill site.

- Manage own workload and completion of assigned MMaR &

- MPaR within established cycle time

- Perform all work in compliance with current SODs and





- 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 Team leader.

- Develop and maintain effective working relationships with internal and external

- Works as a member of a team to achieve all

- Performs all work in support of our Corporate Values of Courage, Passion, Perseverance and Collaboration

- Demonstrates robust and visible support of our values.

- Performs all work in accordance with all established regulatory and compliance and safety

- Works in a safe manner collaborating as a team member to achieve all

- Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.

- 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 2-4 year of experience in the Pharmaceutical industry.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Sr Analyst - Site Support (Mumbai)
🏢 Apotex
📍 Mumbai