Job Description

About the position:

The QC Documentation Specialist is responsible for managing and continuously improving the documentation of the Quality Control and Microbiology laboratory in compliance with Good Manufacturing Practices (GMP) and regulatory requirements. They ensure the application of good documentation practices, maintain and update quality documents, and contribute to data integrity initiatives and continuous improvement.

What You Will Achieve In this role, you will:

- Ensure the creation, update, and tracking of GMP documents under the responsibility of the Quality Control department, including SOPs and instructional documents (CDs). - Manage printing of GMP documentation as Official Print personnel (OPP) and reconciliation of printed documents. - Ensure the archiving of completed documents, including Certificates of Analysis (COAs) for raw materials and stability studies, analysts' laboratory notebooks, obsolete SOPs, and material certificates. Responsible for retrieving archived documents for investigations, trend studies, and inspections. - Responsible for updating and periodically reviewing logbooks in the QC and Microbiology laboratories, ensuring consistent application of ALCOA principles. - Review and compile batch record documents and ensure their communication to Quality Assurance. - Manage QC documentation within document management systems such as PDOCS and track actions in QTS and QMS. - Prepare and manage stability reports for finished products. - Ensure compliance with good documentation practices within the QC laboratory. - Participate in projects related to data integrity and continuous improvement of the QC laboratory.

Here Is What You Need (Minimum Requirements):

- Minimum of 2 years of experience in document management in a similar role. - Excellent writing and communication skills, with the ability to create and review procedures in French and English. - Knowledge of GMP requirements and Good Laboratory Practices (GLP) standards. - Proficiency in Microsoft Office tools (Word, Excel, PowerPoint, Outlook).

Bonus Points If You Have (Preferred Requirements):

- Previous experience in documentation management within a QC laboratory. - Proficiency in document management systems such as PDOCS, GDMS. - Knowledge of quality management systems and CAPA tools such as QTS and QMS.

Work Location Assignment: On Premise

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

Quality Assurance and Control

4932268