Document Specialist

About the role

This role (Network QC Document Specialist) will ensure that data in documents, electronic systems and regulatory filings meet Quality and GMP standards, thereby contributing to Network QC's operational success. Support the development, maintenance and execution of Network QC projects and administrative activities. Perform compliance review of data, technical documents and regulatory filings. Manage the lifecycle of records within the Electronic Document Management System (e.g., Veeva), including the timely completion of periodic reviews. Serve as a key liaison within Network QC to support documentation-related activities, including support for inspection and planned event management. Set personal performance goals and establish work priorities to meet goals and timelines for assignments. Demonstrate a strong focus on customer support and effectively manage stakeholder expectations. Support Network QC and Quality goals while ensuring deliverables are completed in a compliant, accurate and timely manner. A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let's build a healthier future, together. Roche is an Equal Opportunity Employer.

Requirements

• You hold a B.A., B.S. or higher degree (preferably in Life Science or a related field) with 3 - 5 years of applicable cGMP pharmaceutical or biopharmaceutical (or related industry) experience.
• You possess a strong knowledge of industry standards, including ALCOA+ principles, cGMP requirements and ICH guidelines.
• You have experience with Quality Systems, document management and technical writing.
• You have experience collaborating to support global teams and Quality initiatives.
• You have the ability to operate in a self-managed way of working, with a key focus on collaboration and a Quality mindset.
• You have the ability to work in a purpose-driven organization, taking full ownership for assigned roles and tasks.
• Preferred
• Experience in a Quality Control environment is a plus.
• Relocation benefits are not available for this position
• The expected salary range for this position based on the primary location of Mississauga is 89,256.00 and 117,148.50 of hiring range. Actual pay will be determined based on experience, qualifications, and other job-related factors as determined by the company.
• We use artificial intelligence to screen, assess or select applicants for this role.
• This posting is for an existing vacancy at Hoffmann-La Roche Ltd.

Benefits

Additional Information

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche. Quality is a competitive advantage for Roche. It allows us to deliver high-quality products to patients, ensures our right to operate, and helps us bring value through process excellence and continual improvement efforts. Our philosophy - which permeates across the entire Pharmaceutical Technical Operations organization - is that quality is every patient's right and every employee's responsibility.

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