Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Job Description
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:
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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.
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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.
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Ensure SOPs/Forms/WI’s are regularly reviewed and kept up to date with accurate approvals.
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Track status of in-process training, and other activities.
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Assist with the preparation of training materials for SOP training, related training, and SOP summaries as required.
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For each SOP and WI, prepare LMS Form, consisting of a quiz and impacted curricula.
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Routinely supervise training records of all Technical Operations personnel to ensure they remain aligned with training curriculums.
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Work closely with Compliance Department to ensure SOPs/Forms/WI’s are reviewed and revised appropriately and training is provided.
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Assist with preparation of metrics as required.
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Maintain a safe working environment and report potential hazards.
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Perform alternating or rotating shifts (as required)
How will you get here:
Education:
Minimum College/Technical School diploma in Chemistry, Engineering or relevant technical field.
BSc in Chemistry, Engineering or Pharmacy is an asset.
Experience:
Minimum 3 years pharmaceutical experience, preferably in a Manufacturing environment.
Experience with Good Manufacturing Practices and Standard Operating Procedures.
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills, and Abilities:
Strong written and oral communication skills. Detail oriented and organized, with a high degree of accuracy and thoroughness. Good understanding of drug packaging and manufacturing processes. Strong technical writing and oral presentation skills. Ability to recommend improvements relating to pharmaceutical packaging, equipment, processes and systems. Works independently with minimal need for supervision. Works autonomously under general direction to meet objectives. Established quality, regulatory, and production approach including an appreciation for client service and the contract manufacturing industry. Sophisticated experience in MS Word/Excel/PowerPoint. Proficiency with the English Language.
Standards and Expectations:
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.
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 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.
Benefits
We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company savings plan, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
