Compliance Specialist - Quality Agreements

JOB DESCRIPTION

Work Schedule

Environmental Conditions

Job Description

Summary:

To provide primary support for establishing and updating Quality Agreements with PDS and Commercial clients to meet corporate, site, and regulatory requirements . The secondary emphasis , the investigation of Incoming Material Defects, representing quality during Internal, Client, and Regulatory Audits, review of Standard Operating Procedures (SOPs), support Vendor Change Management, and any other function deemed necessary to support Quality Culture within the organization.

Essential Functions: 

• Support preparation of and updating Quality Agreements for PDS and Commercial clients.
• Investigate Incoming Material Defects with input from the vendor, client and internal departments.
• Support Vendor Change Management through assessment of the change to ensure compliance to corporate, site, regulatory and client requirements.
• Participate in the internal, client and regulatory audits.
• Support regulatory requests.
• Oversee the process related to on time retention sample destruction.
• Maintain a safe working environment and reports potential hazards.

REQUIRED QUALIFICATIONS

Education:

College Diploma in relevant technical field

Bachelor of Science (B.Sc.) in chemistry, biology, life sciences or a related field an asset.

Experience:

Minimum 3 years’ experience in a pharmaceutical or related industry.

Previous experience in Compliance or Quality an asset.

Equivalency:

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

Knowledge, Skills and Abilities:

• Knowledge of GMP, HPFBI, FDA and SOP requirements. 
• Excellent interpersonal, organizational, oral, and written communication skills.  Attention to detail.   
• Experience with Technical Writing is a plus
• Proficiency in Documentum an assett
• Proficiency in TrackWise an asset.  
• 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.

Compensation