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

Summary:

To conduct internal, external and client Good Manufacturing Practices (GMP) audits.

Essential Functions:

• Perform internal Good Manufacturing Practices audits of all departments as required and prepare written reports to document the findings.

• Participate in the site Fit and Finish Audit.

• Coordinate site preparations and conduct audits for clients and regulatory inspections including regulatory awareness programs for each agency.

• Assist with ongoing guidance and training of auditors (if applicable).

• Assist with regulatory requests.

• Manage Audit Observations and Audit CAPAs

• Provide administrative support for ongoing Compliance projects.

• Maintain a safe working environment and report potential hazards.

REQUIRED QUALIFICATIONS

Education:

Bachelor of Science (B.Sc.) in chemistry, biology, pharmacy, or other related field

Experience:

Minimum 3 years of Good Manufacturing Practices /Good Lab Practices auditing experience.

Experience with SAP (an asset).

Equivalency:

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

Knowledge, Skills, and Abilities:

Exceptional Good Manufacturing Practices, GLP, and HPBI/FDA compliance knowledge. Proficiency with the use of quality investigation tools – FMEA, Fishbone, etc. Familiarity with SFLMS. Familiarity with managing GMP regulatory requests. Detail-oriented and organized, with a high degree of accuracy and thoroughness. Excellent organizational skills and ability to prioritize in a fast-paced environment. Strong written and oral communication skills. Works well and efficiently with limited supervision. 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 with Patheon quality systems SOPs and Good Manufacturing Practices (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 engaging in problem-solving. Models positive thinking and is open to change, motivating the team to adapt to shift 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, and 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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.