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.)

Summary: Support the Technical Operations department in generation of protocols, master batch record review, batch analysis, Quality Investigation Report/Quality Deviation Report (QIR/QDR) follow-up, process execution and equipment procurement.

Essential Functions:

• Technology transfer. Responsible for transfers and launches to the site. Includes process scale-up and process optimization.
• Investigate quality issues could include system control, Quality Investigation Report (QIR)/Quality Deviation Report (QDR).
• Investigate root causes and recommend appropriate Corrective Action/Preventative Action (CAPA) items for the Technical Operations department (using tools such as FMEA, RCA, etc).
• Generate technical documents (protocols, reports, proposals, gap/risk assessment, batch records, URS, etc).
• Generate, assess, and approve change controls.
• Attend Quality Improvement meetings.
• Assist in the coordination of project information between Account Management, Quality Assurance (QA), Quality Control (QC) and Commercial Operations.
• Support Technical Operations team with process execution/equipment trials and design and acquisition of equipment.
• Perform batch analysis.
• Attend project team meetings, client teleconferences and on-site visits.
• Interact with clients daily.
• Work closely with Technical Writers and Production supervisory staff to ensure timely completion of Commercial manufacturing activities and attends weekly scheduling meetings (if applicable).
• Provide training/support to Co-Ops/Interns and monitor ongoing training (if applicable)
• Maintain a safe working environment and report potential hazards.
• Perform alternating and rotating shift work (as required)

Required Qualifications Education: Post-secondary diploma in Chemistry, Engineering, Science or related field.

BSc in Chemistry or Engineering is preferred.

Experience:

• Minimum 3 years of experience within Pharmaceutical Manufacturing or Quality Assurance departments
• 2 years of combined hands on pharmaceutical experience in Production and Development (scale up and technology transfer of solids and liquids).
• 1-year experience in Master Batch Record/Protocol/Report preparation within the Pharmaceutical Industry, including proven abilities in report writing and batch record preparation required
• Previous experience in statistical analysis and data compilation is preferred
• Previous experience with SAP enterprise software to source information and navigate business operations is preferred.

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

Knowledge, Skills and Abilities:

• Knowledge of processing/packaging equipment.
• Knowledge of current Good Manufacturing Practices and ability to follow Standard Operating Procedures.
• Strong written and oral skills.
• Detail oriented and organized, with a high degree of accuracy and thoroughness.
• Excellent interpersonal skills and communication skills.
• Ability to multi-task, meeting tight deadlines in a fast paced environment. Proven problem solving abilities.
• Demonstrated computer proficiency with Microsoft Office programs. 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 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, 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. Models 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 regular 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 on 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.