Regulatory Specialist II

Posted Yesterday
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Toronto, ON, CAN
In-Office
Junior
Biotech
The Role
Support compliance with ISO, RD, TDG, GMP and WHMIS/EC GHS standards. Perform internal and external audits, handle non-conformances and customer complaints, validate CofAs, manage permits/import limits, contribute to emergency response plans, update procedures, train internal teams, and support quality/regulatory projects and GMP activities.
Summary Generated by Built In

Azelis Canada Inc., among the leaders in the distribution of active ingredients and specialty chemicals, offers a wide range of distinctive services and customized solutions throughout Canada. We provide specialty ingredients and chemicals to the Personal Care, Pharmaceutical, Food & Health, CASE as well as Chemical specialties markets such as lubricants, HI&I, oil & gas and Pulp & Paper. Regulatory expertise and specialized warehousing/logistic capabilities completes our ability to provide a one-stop solution for our clients and global supply partners.  

We are certified under Responsible Distribution Canada and also are ISO 9001:2000 registered which proves our commitment to quality and ethics.

Job Overview:Under the supervision of the SHEQ Manager, Azelis Canada, the employee is primarily responsible for compliance with quality and regulatory standards supporting Azelis operations (ex. ISO, RD, TDG, GMP, WHIMIS / EC GHS.) and the ISO procedures. It provides the link between the department, customers and suppliers to meet the specific needs. It ensures the proper functioning of the quality system to meet the standards and maintain Azelis’s certifications and ensures that all internal units know and apply current rules of SHEQ.Responsibilities and Duties:
  • Ensure compliance with the standard and quality of the overall system in order to maintain certifications and offer services that meet the quality standards of Azelis and needs of customers and suppliers, among others doing:

  • Performing internal audits in accordance with established procedures and deadlines.

  • Performing the external audits for service providers according to established procedures and deadlines.

  • Addressing the demands of non-compliance and complaints of customers and suppliers and to do the required follow-ups until the closing of the files.

  • Establishing or proposing corrective actions and / or preventive actions, depending on the targeted issues during audits, requests for non-compliance or complaints.

  • Ensuring and monitoring the efficiency of the implementation of the chosen corrective and / or preventive actions.

  • Prepare updates to internal and external procedures that support the standards.

  • Ensuring internal and external communications and the implementation of changes to procedures.

  • Validating Certificates of Analysis (CofA) versus the specifications for all products and processes the problems when required.

  • Identifying how to dispose of quarantined products (quarantine warehouse).

  • Establish the import limits of the products.

  • Requesting the permits required by various regulations and performing the follow up if there are any changes in permits and import.

  • Contributing to the development and maintenance of the ERAP plan «emergency response assistance plan»

  • Contributing to the development of the emergency plan in regard to the building, transport and hazardous goods and applying it when necessary.

  • Proceeding with nominations and notifications of products

  • Identifying the impact of changes or added regulations on Azelis operations

  • Understand and resolve common situations by interacting with customers and suppliers and the different departments and bring to the attention of his superior all situations at risk to grow, to ensure at all times a high quality and proactive customer service.

  • Develop expertise in relation to products and the different industries by developing and maintaining current knowledge about the products and services of suppliers in order to, at all times, provide updated information and respond quickly and accurately to customer requests.

  • Develop expertise in relation to the regulations by developing and maintaining current knowledge about the laws and regulations in order to, at all times, provide updated information and respond quickly and accurately to customer requests and suppliers.

  • Ensure the development of internal knowledge of quality and regulatory affairs, including the systems used, by offering information sessions to members of other units to ensure that all have a common understanding of processes related to quality, know how to apply them and can support the operations of the quality and regulatory affairs department.

  • Standardize and document the procedures for carrying out the work to ensure consistency in the execution of tasks and facilitate the substitution.

  • Support other internal departments in handling customer requests and suppliers to offer excellent customer service and develop and maintain a privileged customer relationship that supports the vision of Azelis.

  • Support the Quality and Regulatory Affairs Manager in the implementation of standards relating to health and safety.

  • Support the Quality and Regulatory Affairs Manager in various projects or folders by performing various tasks in meeting deadlines, to facilitate the compliance of the operational management and allow Azelis to achieve its objectives.

  • In case of the absence of the Quality and Regulatory Affairs Manager, the responsibility is transferred to the agent on the activities of Good Manufacturing Practices (GMP).

  • Providing internal support by performing all other responsibilities assigned to it, including the occasional replacement of his colleagues, to allow Azelis to respect its services and / or meet its objectives.

Qualifications:
  • DEC or AEC in an appropriate discipline: quality management, regulatory affairs, chemistry, environmental science, engineering

  • Experience of 1-2 years in a chemical products company (nutri, pharma, etc) in the quality sector or in a laboratory.

  • Already performed internal and external audits

  • Excellent time management skills and priority setting skills.

  • Strong analytical skills, attention to detail and accuracy

  • Demonstrated ability in solving various issues

  • Excellent ability to work in teams in a dynamic environment.

  • Strong ability to adapt and evolve in a dynamic and constantly evolving environment

  • Negotiation skills and political savvy to interact with the various authorities as well as with employees

  • Languages: French; English

  • Computer Skills: Word; Excel; PowerPoint; Outlook; ERP; SharePoint; Quality Software

Skills Required

  • DEC or AEC in quality management, regulatory affairs, chemistry, environmental science, or engineering
  • 1-2 years experience in a chemical products company in quality sector or laboratory
  • Experience performing internal and external audits
  • Knowledge of ISO standards and maintenance of certification (ISO 9001) and Responsible Distribution (RD)
  • Knowledge of TDG, WHMIS / EC GHS, GMP and related regulatory requirements
  • Ability to validate Certificates of Analysis (CofA) against specifications
  • Experience establishing corrective and preventive actions and monitoring their implementation
  • Ability to manage non-conformances, customer and supplier complaints through closure
  • Prepare and update internal and external procedures and implement procedural changes
  • Contribute to ERAP and emergency plans for building, transport and hazardous goods
  • Negotiate and interact with regulatory authorities and internal stakeholders
  • Languages: French and English
  • Computer skills: Word, Excel, PowerPoint, Outlook, ERP, SharePoint, Quality Software
  • Strong analytical skills, attention to detail, accuracy, time management, and problem-solving
  • Ability to train and develop internal knowledge of quality and regulatory affairs
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The Company
Berchem
2,676 Employees

What We Do

As a leading global innovation service provider in the specialty chemicals and food ingredients industry, we are committed to creating value for principals and customers whilst providing a great work environment and career opportunities. Azelis has 4,200+ employees across 65 countries worldwide. We work with around 2,800 principals to provide a diverse range of innovative products/services to 63,000+ customers. Our industry-dedicated sales teams have specialist product and application knowledge, combined with business know-how, enabling us to add value in all business relationships. We’re always looking to add new talent to our team and encourage and support the personal and professional growth of all employees. Specialties include: Life Sciences: Personal Care, Home Care & Industrial Cleaning, Pharma & Healthcare, Food & Nutrition, Animal Nutrition, Agricultural & Environmental Industrial Chemicals: CASE, Electronics, Essential Chemicals, Fine Chemicals, Advanced Materials & Additives, Chemicals, Lubricants & Metal Working Fluids, Other Applications, Textiles, Leather & Paper At Azelis, our partnerships with customers and principals remain at the heart of our activities. As a leading global innovation service provider, our entrepreneurial approach to doing business is reflected in our can-do attitude. Across our network of more than 70 application laboratories, our award-winning staff help develop formulations and provide technical guidance along the customers’ product development process. We combine a global market reach with a local footprint to offer a reliable, integrated and unique digital service to customers and attractive business opportunities to principals. Striving to create a positive impact on the environment and communities around the world, we are top-industry-rated by Sustainalytics. Azelis is a leader in sustainability. We aim to provide effective, sustainable, and reliable solutions. Our business is your business

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