Procedure Coordinator

How will you make am impact:  

Monitor, review, revise, and prepare Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMP) Forms, and Work Instructions (WI’s) within the Operations departments, ensuring they reflect Good Manufacturing Practices, Operation’s procedures, and efficient work activities.   

Location: 2100 Syntex Court, Mississauga, ON. Fully onsite

What will do you:   

• Review, revise and prepare SOPs, GMP Forms, and WI’s for compliance to current Good Manufacturing Practices and to reflect current work activities in Operations departments.  

• Ensure SOPs, Forms, and WI’s for Operations departments are of sufficient detail for technical content, accuracy, clarity, completeness, and flow.  In particular, to Periodic Reviews, Deviation Reports (DRs), comments/audits by clients and regulatory agencies, change controls (CC’s), new/modified equipment, facility changes, committee findings, and general changes in procedures.   

• Ensure SOPs/Forms/WI’s are regularly reviewed and kept up to date with accurate approvals.  

• For each SOP and WI, prepare LMS Form, consisting of a quiz and impacted curricula.  

• Routinely supervise training records of all Technical Operations personnel to ensure they remain aligned with training curriculums. 

• Work closely with Compliance Department to ensure SOPs/Forms/WI’s are reviewed and revised appropriately and training is provided.    

• Assist with preparation of metrics as required.  

• Maintain a safe working environment and report potential hazards. 

• Perform alternating or rotating shifts (as required) 

Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively 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 Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion.  Effectively engage in and adhere to departmental systems to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). 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. Model positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner.  Consistently strives to improve skills and knowledge in related field.     

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 acutes, 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.