Documentation Specialist

Grifols; Mississauga; On-site; CAD 55,000 - 85,000; Full time

Job summary

Grifols, S.A. in Mississauga, Canada is seeking a Documentation Specialist to support the QA department by controlling GMP documentation, filing, tracking and archiving. You will maintain document control systems and ensure compliance with quality and regulatory requirements.

The role requires a Bachelor’s degree in health-related sciences and 2+ years in plasma collection or pharmaceutical industry. Proficiency with Microsoft Office and knowledge of Health Canada, FDA and EMA GMP regulations

Qualifications

• Bachelor’s degree in health-related sciences.
• Minimum two years of blood/plasma collection or pharmaceutical industry experience.
• Understanding of quality management systems and related regulations.
• Ability to understand, explain, follow, and enforce SOPs and protocols.
• Experience in change and deviation management preferred.
• Proficiency in Microsoft Office Suite (Word, Outlook, Excel).
• Understanding of Health Canada, FDA and EMA GMP regulations.
• Able to work in a highly regulated, labor-intensive environment.

Responsibilities

• Maintain GMP document templates and tracking systems such as SOPs, forms, protocols and reports.
• Oversee the change control process, including tracking and coordinating changes, circulating requests for approval, preparing documents, distribution of approved changes
• Other related duties/responsibilities as required by the Quality System Manager.
• Review SOPs related to Documentation Lifecycle Systems, following guidelines per Canadian regulations and cGMP requirements.
• Ensure compile of information related to Documentation Lifecycle referred to KPIs established for the Quality system.
• Define a system of control of documentation within the Quality Management System to keep documents updated.
• Compile and prepare Grifols viral marker data for PPTA reporting.
• Perform assigned tasks by direct manager.

Skills

Quality management

SOP adherence

Documentation control

Time management

Education

Bachelor’s Degree in Health-related Sciences

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

Job description

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Position title: Documentation Specialist

Reports to: Quality Management System Manager

Position Summary:

The Documentation Specialist provides support to the QA department in controlling GMP documentation processing, filing, tracking and archiving. The individual maintains various data bases for document tracking and maintains QA operations file.

Position Objective:

The Documentation Specialist is responsible for maintaining the document control system and monitoring, tracking, and recording all activities that directly or indirectly impact product quality, donor suitability, donor safety, plasma testing, and plasma warehouse operations. The role ensures that documentation processes are effectively managed and maintained in compliance with applicable quality and regulatory requirements.

The Documentation Specialist is also responsible for implementing appropriate controls to ensure the accuracy, integrity, availability, and legibility of all controlled documents, supporting the reliability of records and the overall effectiveness of the quality management system.

Position Responsibilities:

• Maintain GMP document templates and tracking systems such as but not limited to: SOPs, forms, protocols and reports.
• Oversee the change control process, including but not limited to: tracking and coordinating changes, circulating requests for approval, preparing documents, distribution of approved changes
• Other related duties/responsibilities as required or assigned by the Quality System Manager. To ensure proper implementation of document control systems in GEPD plasma supply chain areas.
• Review SOPs related to Documentation Lifecycle Systems, following the guidelines established according to Canadian regulations and the guidelines established according to cGMP requirements and Good Documentation Practices.
• Ensure compile of all the information related to Documentation Lifecycle referred to Key Process indicators established for the Quality system.
• To define a system of control of documentation that ensures that documents within the Quality Management System should be regularly reviewed and kept up to date.
• Compile and prepare Grifols viral marker data for PPTA reporting.
• Perform assigned tasks by direct manager.

Required Skills, Qualifications and Experience:

• Bachelor ‘s Degree in Health-related Sciences.
• Minimum two (2) years of Blood/plasma collection or pharmaceutical industry experience.
• Understanding of quality management systems and related regulations is required.
• Ability to understand, explain, follow, and enforce SOPs and protocols.
• Experience in change and deviation management preferred.
• Proficiency in Microsoft Office Suite (Word, Outlook, Excel).
• Understanding of Health Canada, FDA and EMA GMP regulations. Organized and able to manage time effectively.
• Ability to work within a highly regulated, labor intensive environment.
• Ability to understand, explain, follow, and enforce SOPs and protocols.
• Ability to plan, communicate and execute activities for the improvement of overall operations.
• Strong integrity and commitment to Quality and Compliance.
• Excellent oral and written communication skills to produce clear and concise factual findings and ability to present effectively to groups.

The salary range for this position is currently being assessed and will be disclosed upon completion of the compensation review process, in accordance with applicable transparency requirements.