Technical Writer

The Technical Writer is responsible for crafting and updating cGMP (Current Good Manufacturing Practices) documentation for Operations processes and equipment, including standard operating procedures, work instructions, master batch records and general administrative procedures. This position reports to the Senior Production Manager.

• Documentation Architecture: Develop and implement an efficient documentation architecture for the manufacturing processes.
• Documentation Creation: Demonstrated ability to develop and maintain clear, concise, and compliant documentation, including standard operating procedures (SOPs), work instructions, forms, reports, technical manuals, Batch Records, and protocols, following Good Documentation Practices (GDP) principles.
• Process Documentation: Collaborate with subject matter experts (SMEs) to document manufacturing processes. Ensure accuracy and adherence to industry standards.
• Quality: Review and revise documents for accuracy, completeness, and compliance with regulatory requirements. Implement version control and change management processes. Writing technical investigations and deviation reports when required.
• Regulatory Compliance: Remain up to date with regulatory changes in the industry and ensure all documentation meets or exceeds these requirements.
• Training Support: Drive the development of training materials and conduct stream-lined training sessions for employees to ensure they understand and follow documented procedures.
• Prepare training packages, training documentation and help drive the execution of training to the production team, in collaboration with Production SMEs, Tech Services, and Operations Trainer.
• Cross-functional Collaboration: Work closely with various departments, including Product Development, Quality Assurance, Manufacturing, Facilities & Engineering, and Environment Health Safety (EHS) to gather information and improve documentation processes.
• Continuous Improvement: Demonstrated ability to identify opportunities to streamline documentation processes, improve document accessibility, and enhance overall efficiency in alignment with Lean Management principles; lead and execute those improvements to completion. Proactively identify and improve inefficient processes.
• Supporting and monitoring the change control (CCR) process, facilitating the impact assessment and updating of any related SOP’s, work instructions, forms, reports, manuals and protocols.
• Technical Writing Standards: Uphold high standards of technical writing, ensuring documents are clear, concise, and easily comprehensible by the intended audience. Review documents for logic, clarity, comprehensiveness, relevance and organization, format, flow, grammar, punctuation, and spelling for compliance with customer standards, style guidance, and publication policies. Able to distill complex terms into something simple, visual and easily comprehendible.
• Observes and supports all safety guidelines and regulations.
• Follows GMP and regulatory requirements, and ensures quality standards are met.
• Demonstrates the Company Mission, Vision and Values Statements, policies, and current standard business practices.
• Performs other required tasks as assigned.

Education

• Bachelor’s Degree in a relevant scientific discipline.

Experience

• 3 years of industry experience working with Good Documentation Practices (GDP) in a relevant industry (Pharmaceutical or Biotechnology preferred).
• Equivalent combinations of education, training, and relevant work experience may be considered.
• Proven experience as a technical writer with a strong understanding of Good
• Documentation Practices (GDP) and Good Manufacturing Practices (cGMP).
• Experience in creation and revision with both paper based, and electronic versions of Standard Operating Procedures (SOPs) and Manufacturing Batch Records (MBRs) or electronic Batch Records (eBR).
• Knowledge of Good Manufacturing Practices and CA/US/EU regulations.
• Proficient in Microsoft Office applications.

Knowledge, Skills and Abilities

• Self-motivated and able to identify project needs and following that up with building and implementing solutions.
• Excellent written and verbal communication skills, with the ability to convey complex technical information, clearly and concisely.
• Shown success working in cross functional teams, ability to work collaboratively, and provide proactive communication.
• Organized, efficient, and results oriented with ability to work under pressure and meet tight deadlines.
• Strong understanding of manufacturing processes, equipment, and procedures.
• Proficient in document management systems and software tools.
• Experience with electronic Batch Records (eBR) would be an asset.
• Adept at using innovative methods including visual aids and technology.
• Attention to detail and accuracy.
• Time management and organizational abilities.
• Knowledge of industry standards and regulatory requirements.
• Strong knowledge of documentation methodologies and requirements.

We are committed to diversity and inclusion, and thank all applicants in advance; however, we will be corresponding only with those selected for an interview.

In accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act, we are committed to providing an inclusive and barrier free recruitment and selection process.

Recruitment Fraud – please be aware of recruitment fraud. Novocol Pharmaceutical of Canada Inc. will never ask for banking information, money or any personal information up front. We will only respond to official applications submitted through our careers site. In addition, we will only use official corporate e-mail addresses (septodont.com or novocolpharma.com) to communicate with applicants. Should you be contacted without submitting an application, please delete the message and advise your e-mail provider.

Internal Job Posting Grade 9B. The due date for internal applicants to apply for this role is February 13, 2024.