Job Description

　　Technical Writer II - Technical Operations

　　Summary:

　　Prepares and revises master batch records (MBRs) for manufacturing and packaging and provides input, supports and assistances the Technical Operations, Pharmaceutics & Process Technology (PPT) and Operations groups. Assists with maintaining up to date MBR templates and completes improvement projects related to technical writing.

　　Essential Functions:

　　Works closely with the Technical Operations, PPT Engineers and commercial departments in the generation and approval of work orders.Works with internal teams addresses client commentsGenerates and develops all master batch records used in Good Manufacturing Practices environment.Works closely with Engineers, Business and Project Managers to understand requirements for each MBR.Attends key project team meetings, client teleconferences and on-site visits.Creates change controls and attends CC committee meetingsAssists Technical Operations and PPT group as required.May be required to assist with report generation from Systems, Applications and Products (SAP).Updates and maintains MBR templates to comply with current practices in Operations and PPTMaintains a safe working environment and reports potential hazards.

　　May be essential to perform alternating or rotating shift work (as required).

　　REQUIRED QUALIFICATIONS

　　Education:

　　College Diploma in Science/Technical related field.

　　Experience:

　　Minimum 3 years related experience.

　　Equivalency:

　　Equivalent combinations of education, training, and relevant work experience may be considered.

　　Knowledge, Skills and Abilities:

　　Strong written and oral communication skills. Must be well organized and detail oriented. Ablity to to lead improvement projects. Knowledge of Good Manufacturing Practices and ability to follow Standard Operating Procedures (SOPs). Ability to work under pressure and meet tight deadlines. Proficiency with Microsoft Office applications. Proficiency with the English Language.

　　Standards and Expectations:

　　Follow all Environmental Health & Safety Policies and Procedures. Work harmoniously with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality systems SOP's and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems, shared assets). Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identifies areas for improvement in the execution of department procedures. Communicate risks to timelines of deliverables in a proactive manner. Consistently strives to improve skills and knowledge in pharmaceutical development (an asset).

　　Physical Requirements:

　　There is little physical effort and fatigue. Walks, stands, lifts small objects and tools, and/or operates keyboard equipment for short duration (eg. lifts very light items such as a stapler). Regular need to attend to and decipher sensory input that requires diligence and attention to interpret effectively. This is typically because data is technical, legal or financial in nature. (e.g., troubleshooting systems software and hardware problems, analysis of budget statements). Located in a comfortable indoor area. Any unpleasant conditions would be infrequent and of short duration.

　　Disclaimer:

　　This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

　　Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.