Work Schedule Standard Office Hours (40/wk) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office Job Description Summary: Monitor, review, revise, and prepare Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMP) Forms, Work Instructions (WI’s), technical documents ensuring they reflect current Good Manufacturing Practices, Operation’s procedures, and efficient work activities. Essential Functions: o Review, revise and prepare SOPs, GMP Forms, and WI’s for compliance with current Good Manufacturing Practices and to reflect current work activities in Operations departments. o Ensure SOPs, Forms, and WI’s for Operations departments are of sufficient detail for technical content, accuracy, clarity, completeness, and flow. o In particular, SOPs/Forms/WI’s/Technical documents in response 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. o Ensure SOPs/Forms/WI’s are regularly reviewed and kept up to date with proper approvals. ? Track status of in-process SOPs, Forms, and WI’s training, and other activities. ? Prepare technical documents for validation activities, Periodic Reviews and elemental assessments. ? Support data collection for cleaning validation and other validation programs ? Scan, electronically store, photocopy, distribute, file and archive validation document and manages offsite document archival ? Assist with the preparation of training materials for SOP training, related training, and SOP summaries as required. ? 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, technical projects, data compilation, data verification as required. ? Maintain a safe working environment and report potential hazards. ? Perform alternating or rotating shifts (as required) REQUIRED QUALIFICATIONS 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 meaningful 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 project and team objectives. Established quality, regulatory, and production approach including an appreciation for client service and the contract manufacturing industry. Well experienced in MS Word/Excel/PowerPoint. Proficiency with the English Language. Standards and Expectations: Follow all Environmental Health & Safety Policies and Procedures. Work with fellow team members, modelling positive team principles and meet project and departmental objectives. Carry out all duties within strict compliance with Patheon quality systems Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Effectively engage in and carry out 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. 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. Relocation assistance is NOT provided Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. COVID-19 Vaccination Update for U.S. & Canada Colleagues All U.S. colleagues are required to disclose their COVID-19 vaccination status. New hires will be asked to disclose their vaccination status upon the first day of employment. U.S. new hires (including those in Field Sales, Field Services and Customer Support - Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. U.S. and Canada new hires in Clinical Research who are in the following job categories must be fully vaccinated before their first day of employment or request an accommodation: executive director level and above, client-facing commercial, clinical research associates (CRAs), Assistant CRA (ACRAs), all CRA and ACRA line managers, clinic-based staff in early development services and accelerated enrollment solutions, and FSP within analytical services division roles. Canada new hires (including those in Field Sales, Field Services, and Customer Support Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. New hires in Field Sales, Field Services, and Customer Support Technical Applications will be asked to disclose their vaccination status upon the first day of employment. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
