Compliance Auditor

1 week ago

Whitby, Canada Thermo Fisher Scientific Full time

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

**Essential Functions**:

- Performs internal Good Manufacturing Practices audits of all departments as required and prepares written report to document the findings.
- Participates in the site Fit and Finish Audit.
- Facilitates site preparations and auditing executions for clients and regulatory audits as well as regulatory awareness programs for each agency.
- Assists with ongoing guidance and training of junior auditors (if applicable).
- Assists with regulatory requests.
- Manages Audit Observations, Responses, and CAPAs.
- Provides administrative support for ongoing Compliance projects.
**REQUIRED QUALIFICATIONS**
**Education**:

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

- Minimum 3 years Good Manufacturing Practices /Good Lab Practices auditing experience.
- 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. Experience with SAP (an asset). Detail oriented and organized, with a high degree of accuracy and thoroughness. Excellent organizational skills and ability to prioritize in a face-pace 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.

**Core Competencies**:
Put the Customer First - Think and act with a customer-centric mindset to deliver exceptional customer experiences. Own Your Results - Take personal accountability for all you do and always exercise good judgement. Find a Better Way Everyday - Be intellectually curious and embrace Practical Process Improvement (PPI).
Standards and Expectations:
Comply with all Environmental Health & Safety Policies and Procedures. Work harmoniously 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 SOPs 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 (KPIs) 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 of deliverables 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 an exhaustive statement of duties, 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 comply 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.

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