Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Business Title: Project Leader I - Quality
Effective Date: 06.MAR.2023
Revision #: 1
Version #: 2.0, CURRENT
Replaces: 20.MAY.2021
Summary:
Manage a portfolio of Clients and update quality plans/quality performance for clients, supports product transfers from Pharmaceutical Development Services (PDS) and external to Commercial operations. Provide on floor Quality (Q) support, attend RAPIDS and performs deviation investigations. Participate in Failure Mode and Effect Analysis (FMEAs) and process improvements determined from trending data.
Essential Functions:
Manage multiple small-medium projects and/or improvement initiatives
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Lead risk analyses
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Assure continuous Quality improvement in plant related to trends from Quality systems
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Lead Quality initiatives, and provide Q support throughout the facility, quality assessments on process improvement activities such as Mini Ts, Kaizens
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Work with management to resolve project issues and resource constraints within the team.
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Support decision making on projects and future directions by trending deviations in Global Track Wise (GTW)
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Maintain positive team member interactions and manages conflict with assistance from Quality Manager
Plan, monitor, and ensure completion of Metrics, CAPAs and quality approvals
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Support Quality investigations related to Site, Incoming material, Complaints and products
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Facilitate content of Quality Huddles, represent Quality at RAPIDs, and material under investigation
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Prepare Quality Agreements for approval
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Assure GTW compliance
Manage client satisfaction by updating quality plans and coordinates customer requests
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Manage a portfolio of Clients of moderate to high complexity and will be the key contact
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Monitor Voice of the Client (VOC) and builds improvement plans
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Prepare quality presentations for Client meetings and present
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Support PAI or Client audits as necessary
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Support the implementation of Quality Agreements
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Maintain a safe working environment and report potential hazards.
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Perform alternating or rotating shift work (as required)
REQUIRED QUALIFICATIONS
Education:
College/Technical School Diploma in related field
Bachelor of Science (B.Sc.) in Chemistry, Pharmacy, Microbiology, or Engineering an asset
Experience:
Minimum 5 years of previous related experience in pharmaceutical/food/cosmetic industry, preferably in a QA function
Minimum 2 years pharmaceutical development experience
Project management experience or client management experience an asset
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills and Abilities:
Strong self-motived individual. Ability to work independently, and within a team environment. Well organized and detail oriented with the ability to meet deadlines. Ability to prioritize multiple tasks. Strong interpersonal skills. Experience with Good Manufacturing Practices. Established quality, regulatory, and production mentality including an appreciation for client service and the contract manufacturing industry. Excellent written and oral communication skills. Proficiency using MS Office applications. Proficiency with 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 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.
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 a comprehensive statement of work, 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 align 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.
