Business Title: Technical Writer III - Technical Operations
Effective Date: 03.APR.2023
Revision #: 1
Version #: 2.0, CURRENT
Prepare and revise master batch records (MBRs) for manufacturing and packaging and provides input, support and assistance to the Technical Operations, Pharmaceutics & Process Technology (PPT) and Operations groups. Work with Engineering groups to maintain MBR templates and participates in improvement efforts to better improve processes withing the Technical Writing department.
- Work closely with the Technical Operations, PPT Engineers and commercial departments in the generation and approval of work orders.
- Generate and develop all master batch records used in Good Manufacturing Practices environment.
- Maintain and upgrade the MBR templates to comform to current practices
- Work closely with Engineers, Business and Project Managers to understand requirements for each MBR.
- Attend key project team meetings, client teleconferences and on-site visits. May be required to participate in improvement events on behalf of the Technical writing department.
- Perform investigations relating to deficiencies within the department
- Assign change controls and techinical packages to the Technical Writers
- Maintain internal logs and metrics.
- Create change controls (as required)
- May be required to assist with report generation from Systems, Applications and Products (SAP).
- Maintain a safe working environment and reports potential hazards.
- Perform alternating or rotating shift work (as required).
College Diploma in Science/Technical related field.
Minimum 4 years related experience.
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 :
Light physical effort and fatigue. Walks, sits or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area. There may be exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights. Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator occasionally.