Field Validation Specialist – cGMP & QA

Grifols Shared Services North America, Inc; Toronto; On-site; CAD 70,000 - 90,000; Full time

Job summary

Grifols Canada is seeking a Field Validation Specialist to ensure cGMP compliance across donor centers and to perform validation testing, documentation, and review of protocols. The role involves travel to donor center sites to conduct Operational Qualification and Performance Qualification testing.

You will collaborate with Donor Center teams and Quality/Operations to meet regulatory expectations, prepare validation reports, and support calibration and equipment validation activities across

Qualifications

• Bachelor's degree required.
• Typically requires 2 years of quality and validation experience in a cGMP and/or IT environment.
• Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures.
• Excellent quantitative and analytical skills.

Responsibilities

• Interacts with Donor Center and Field Quality/Operations personnel to facilitate validation testing to ensure timely and documented approval prior to implementation for routine use.
• Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry
• Executes freezer installation, operational, and performance qualifications on-site at donor centers and other affiliated locations.
• Assists in analyzing validation data to ensure acceptance criteria are met and participates in writing validation summaries.
• Communicates with Field Quality/Operations and other Operational and Quality Assurance personnel where necessary on Donor Center compliance and cGMP issues.
• Writes test cases to validate critical control points, user requirements, and functional designs.

Skills

cGMP knowledge

Quality systems

Analytical skills

Communication skills

Team player

Microsoft Office

Education

Bachelor's degree

Tools

MS Office

Job description

Grifols Canada is seeking a Field Validation Specialist to ensure cGMP compliance across donor centers and to perform validation testing, documentation, and review of protocols. The role involves travel to donor center sites to conduct Operational Qualification and Performance Qualification testing.

You will collaborate with Donor Center teams and Quality/Operations to meet regulatory expectations, prepare validation reports, and support calibration and equipment validation activities across