Pfizer Document Optimization in Chennai, India

ROLE SUMMARY:

  • Team Member for site documentation optimization project

  • Will be part of a cross functional team responsible for optimizing and simplifying all levels of documentation including SOPs, Batch Records etc across a sterile injectables manufacturing site

  • The project scope will also involve optimization and synchronization of process/documentation relationship.

ROLE RESPONSIBILITIES

This position is responsible for:

  • The correct and timely delivery of optimized documentation that comply with GMP and GDP requirements within a department or quality system

  • Ensure end results are designed to mitigate Human Errors and reinforce Data Reliability

  • End to End project deliverables of the project from Scoping of documentation till final approval of the respective documents.

  • To understand end user requirements e.g. Shop floor employee requirements for Batch Record documentation.

  • Ability to gain insight into the diverse processes in sterile injectables manufacturing and apply this knowledge in the creation of simplified instructions and procedures

  • Ensuring all documentation delivered as part of the project complies with the Pfizer writing methodology, the documentation and training principles, and is written according to the applicable writing agreements.

  • Check and ensure that all instructions and procedures of quality systems are in line with the operational work instructions and procedures.

  • Being the point of contact for the departments regarding documentation, to assess the impact on this if the working methods or standards change.

  • Work within the Quality system including usage of Pfizer Document Management system to ensure Quality and Compliance

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.