Quality Systems Specialist, Quality Assurance Conformity (BQ)

Job Description

A collective energy and ambition. A place where you can make a real difference.

We’re a company that genuinely cares about our people, our products, our consumers and the environment.

Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership. We have a shared passion to work hard, innovate and push boundaries.

United by the belief that when we strive for growth, anything is possible. While we might not be the largest company in our industry, we believe we can have the biggest impact because: Together We Have the Power to Win.

Title:                     Quality Systems Specialist, Quality Assurance Conformity (BQ)

POSITION SCOPE:

The Quality Systems Specialist is an expert in compliance and quality systems. The main responsibilities of the position relate to the management of projects and activities in order to ensure and maintain the conformity of the plant and the products. The Quality Systems Specialist is a unifying member and acts as a leader within multifunctional teams whose goal is to maintain quality systems in compliance with regulatory requirements and to identify opportunities for continuous improvement. The specialist will ensure regulatory monitoring in order to meet these requirements and address any shortcomings.

RESPONSIBILITIES AND TASKS

Quality Systems

• Provides oversight of quality systems and provides quality support to operations when quality issues or questions arise.
• Performs the risk assessment with respect to the discrepancies and non-conformities observed and makes recommendations.
• Participates in the drafting/revision and/or approval of standard operating procedures (SOPs) for the quality department.
• Provides support during audits (internal, external and corporate). May also perform internal audits.
• Proposes solutions for continuous improvement and solutions to improve quality systems in general.
• Performs the risk assessment relative to the discrepancies and non-conformities observed and makes strategic recommendations.
• Compiles data and generates KPIs related to quality systems, analyzes, interprets and issues strategic recommendations.
• Performs all other related tasks.

Administrator and expert (SME) of the electronic system for the management of controlled documents.

• Coordinates the organization of official documentation.
• Ensures the review and approval of controlled documents (including but not limited to SOPs, MBR/PBR, Specifications, Methods, etc.) by subject matter experts and according to the schedule.

• Ensures consistency between the various official documents of C&D Canada, GMPs and applicable regulations and judges the relevance of the changes that are proposed.
• Offers support to the various departments of the plant in terms of documentation.
• Acts as subject matter expert when reviewing Standard Operating Procedures (SOPs).

Training program

• Provide employee training before implementing new controlled documents when required (eg: SOP).
• Ensures employee training records are up to date and trained on current versions of SOPs relevant to their duties.
• Participates in the development of training aimed at all employees (eg GMP training, basic training for new employees).
• Provides basic GMP training to new employees.

Change Controls / Deviations / Events

• Acts as a Change Analyst.
• Handles change and event controls from subcontractors or external partners, assessing their impacts and the actions identified. Ensures that they do not conflict with existing procedures, GMPs or applicable regulations.
• Evaluates changes and deviations ensuring they are aligned with internal procedures and regulatory requirements.
• Ensures the progress of change controls, performs follow-ups, closure of actions, etc.
• Compiles data and generates associated KPIs.
• Acts as a coordinator and ensures proper follow-up of actions.
• Responsible for the management of CAPAs aimed at correcting the causes and contributing factors of quality problems.
• Uses problem-solving tools to improve facility quality performance.
• Proposes sustainable solutions to improve C&D GMP compliance.

Investigations and CAPAs

• Acts as primary investigator and oversees multi-functional and multi-site investigations of complex issues.
• Is responsible for the investigation of non-conformities of all kinds (including but not limited to deviations, complaints, etc.) affecting products intended for the Canadian market.
• Works in close collaboration with the Quality Compliance team, as well as the operational teams of the factories impacted in order to achieve the targets established in terms of release.
• Brings together, if necessary, the various experts in the field in order to identify the causes of deviations and find the most relevant and robust CAPAs.
• Manages and coordinates CAPAs, presents recommendations regarding preventive and corrective measures in order to avoid a repetition of deviations. Ensures the closing of actions according to the prescribed deadlines. Is responsible for confirming the effectiveness of identified CAPAs.

• Reviews incidents to ensure problem resolution according to GMPs and C&D Corp policies. Ensures that deviation reports are complete, understandable and truthful.
• Uses investigative practices and/or statistical techniques to properly identify GMP deviations and to identify the root cause.
• Acts as a leader of cross-functional groups by guiding them in the management of deviations or quality problems.
• Compiles data and generates KPIs related to events and non-conformities, analyzes, interprets and issues strategic recommendations.

QUALIFICATIONS

• Bachelor’ degree in  Science, Chemistry or other relevant disciplines
• Minimum of 5 years of experience with Quality Systems in relation to deviations, investigations, results out of specification (OOS), corrective and preventive actions (CAPA), change controls and complaints in the pharmaceutical industry
• Excellent knowledge of Canadian food and drug regulations, FDA and ISO 13485 standard
• Ability to read and interpret the various regulatory guides and technical procedures
• Ability to analyze and process data in order to draw appropriate conclusions
• Skill in project management
• Knowledge and good understanding of materials, products, pharmaceutical manufacturing and packaging processes
• Strong ability to manage multiple priorities in a constantly changing environment
• Excellent computer skills and writing abilities
• Excellent communication skills, interpersonal skills and attention to detail. Capable of working effectively in teams. 
• Bilingualism (French & English) preferred
• Knowledge of the following computer systems: Microsoft office suite, SAP, Solabs & Swisslog
• Certification in lean six sigma would be an asset

Church and Dwight Canada is an equal opportunity employer committed to providing a barrier-free, inclusive and accessible work environment. Applicants may be entitled to reasonable accommodation in respect of a legally protected characteristic in accordance with applicable human rights legislation. If you require accommodation on this basis, we will work with you to meet your needs. Please inform our Human Resources department if you require an accommodation in completing this application for employment or for otherwise participating in the application process.