Compliance Specialist

7 days ago


Whitby, Canada Thermo Fisher Scientific Full time

**Summary**:
Support creation and maintenance of Quality Agreements and the execution of the Vendor Management Program to ensure compliance to regulatory and corporate requirements at Whitby Region Operations (WRO). Support continuous improvement of the Quality Agreement and Vendor Management programs. Collaborate cross functionally for Quality Agreement and Vendor Management issue resolution. Support regulatory, corporate, client and internal audits.

**Essential Functions**:

- Management and maintenance of Vendor Database, vendor files, and associated documentation.
- Support the preparation of Vendor Status Reports.
- Perform vendor related investigations and risk assessments.
- Creation of manufacturer and supplier records associated with the creation of new material and component records (i.e. API, excipients, packaging components).
- Change Control initiation and / or pre-assessment for existing manufacturer, supplier, material, or component records.
- Support creation of Quality Agreements for new clients.
- Maintain periodic (triennial) review process of Quality Agreements.
- Support the maintenance of Quality Assurance Database.
- Collaborate cross functionally to support the site with Vendor Management and Quality Agreement matters to ensure compliance to requirements (i.e. issue resolution, etc.).
- Author Vendor Management and Quality Agreement related SOPs and WIs as required.
- Support continuous improvement of Vendor Management and Quality Agreements through Practical Process Improvement (PPI) concepts.
- Generate metrics for Quality Agreements and Vendor Management to track, trend, and monitor for performance and compliance.
- Support regulatory, corporate, client, and internal audits.
- Comply with all global and site policies and procedures.
- Maintain a safe working environment and reports potential hazards.

**REQUIRED QUALIFICATIONS**

**Education**:
College Diploma in relevant technical field

Bachelor of Science (B.Sc.) an asset.

**Experience**:
Minimum 3 years experience in the pharmaceutical industry.

Previous experience in Compliance or Quality Assurance an asset.

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

**Knowledge, Skills and Abilities**:
Demonstrated computer proficiency with Microsoft Office programs. Strong ideas, decision making abilities, trouble shooting and thinking-out-of-the-box skills. Excellent organizational, verbal and written communication skills. Familiarity with GMPs. Works well with limited supervision. Excellent organizational, interpersonal, oral and written communication skills. Experience in Microsoft Word, Excel, Access. Experience with EDMS, SuccessFactors LMS is an asset. 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 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 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 he



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