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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in GMP documentation control, quality management systems, and regulatory compliance, with a strong focus on maintaining accurate documentation and effective communication within a highly regulated environment.
Highest-signal resume keywords
GMP Documentation ControlQuality Management SystemsChange Control ProcessSOP Development and EnforcementMicrosoft Office Suite Proficiency
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
GMP Documentation ProcessingDocument Tracking SystemsQuality System Key Performance IndicatorsChange and Deviation ManagementDocumentation Lifecycle Systems
Soft Skills
Organizational SkillsTime ManagementEffective CommunicationIntegrity and Commitment to Quality
Certifications & Qualifications
Bachelor's Degree in Health-related Sciences
Industry Keywords
Blood/Plasma CollectionPharmaceutical IndustryHealth Canada RegulationsFDA RegulationsEMA GMP Regulations
About the role
Key responsibilities & impact- Provide support to the QA department in controlling GMP documentation processing, filing, tracking and archiving
- Maintain databases for document tracking and maintain QA operations files
- Maintain GMP document templates and tracking systems, including SOPs, forms, protocols and reports
- Oversee the change control process, including tracking and coordinating changes, circulating requests for approval, preparing documents, and distributing approved changes
- Implement document control systems in GEPD plasma supply chain areas
- Review SOPs related to Documentation Lifecycle Systems according to Canadian regulations, cGMP requirements and Good Documentation Practices
- Compile information related to Documentation Lifecycle key performance indicators for the Quality system
- Define a documentation control system ensuring Quality Management System documents are regularly reviewed and kept up to date
- Compile and prepare Grifols viral marker data for PPTA reporting
- Perform assigned tasks by the direct manager
Requirements
What you’ll need- 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 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