Quality systems specialist managing controlled-document lifecycles and compliance for Grifols, a global healthcare company. Supporting audits, archives, GDP, cGMP, and electronic document systems.
Responsibilities
Maintain and administer the site's document management system
Coordinate the complete lifecycle of controlled documents, including SOPs, forms, work instructions, specifications, and quality records
Review documents for compliance with formatting standards, regulatory requirements, and internal procedures
Manage Document Management System requests and monitor associated timelines
Coordinate document review, approval, issuance, distribution, and obsolescence activities
Track periodic document reviews and follow up with document owners
Manage the archive system according to retention requirements and internal procedures
Administer the archive room and coordinate document retrieval, storage, transfer, and destruction
Coordinate the issuance, control, reconciliation, and maintenance of GMP logbooks
Oversee controlled printing, including issuance, tracking, and reconciliation
Maintain document control metrics and prepare quality system monitoring reports
Support internal audits and regulatory inspections by providing required documentation and records
Train and guide employees on document management procedures and Good Documentation Practices
Participate in continuous improvement initiatives related to document management and quality systems
Comply with cGMP requirements, quality procedures, and departmental safety practices
Requirements
Bachelor's degree in Science, Engineering, Business Administration, or a related field, or an equivalent combination of education and experience
Minimum of four years of experience in a regulated environment such as pharmaceutical, biotechnology, medical device, or related industries
Strong experience in document control, document management, or quality systems administration
Working knowledge of cGMP regulations, Good Documentation Practices (GDP), and applicable regulatory requirements (FDA, Health Canada, EudraLex, PIC/S)
Experience with Electronic Document Management Systems (EDMS) and change control systems
Strong organizational skills with the ability to manage multiple priorities and deadlines
Excellent written and verbal communication skills
Bilingualism (French and English) required
English proficiency required for documentation exchanges and communications with Grifols sites outside Quebec and Canada, including Spain and the United States
Benefits
Regular Full-Time employment
International team at a global healthcare company
Work contributing to healthcare and improved health and well-being
Opportunities to participate in continuous improvement initiatives
Training and guidance provided to employees on document management procedures and Good Documentation Practices (GDP)
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