Hseq and Regulatory Affairs Specialist

2 months ago

Brampton, Canada IMCD Canada Ltd Full time

**Job Purpose**
This position helps coordinate activities to meet and comply with all pertinent Canadian and US laws and regulations governing our business activities. The position assists all IMCD Canada and US Food teams, our principals and customers in meeting requirements relating to safe and proper handling of food & fine chemicals, pharmaceutical ingredients, and industrial products. IMCD will further define the roles of the HSEQ department such that a better focus can be placed on the Regulatory, Quality, Environment and Health & Safety activities at both a local and regional level.

The Quality and Regulatory Affairs Specialist is experienced and skilled in the quality and regulatory field, with a focus on improvement of processes in these areas to reduce risk corporately. The position includes in
- depth knowledge about Quality Management Systems and Federal Regulatory Requirements at both a Food (including Pet Food), Pharma, and Industrial level including the management of all elements of a Food Safety Program (HACCP). In addition, the Quality/Regulatory Specialist will play a lead role in ensuring federal compliance providing support to internal and external customers in all areas as they pertain to Pharma/ Food Safety and Regulations.

Ensure that all the actions required to maintain the ISO and Responsible Distribution certifications and establishment licenses are put forward. At all times, Quality/Regulatory Specialist must ensure that the transactions of IMCD Canada, complies with the quality standards and regulations in force. Quality/Regulatory Specialist must be constantly on the lookout for changes and ensure that they are communicated effectively internally so that they are taken into account in the decisions and processing of transactions.

The role will be part of a small central team, reporting to the HSEQ and Regulatory Director and contributes to the collection, management compliance check and accuracy of the data. The team enables effective governance and workflow management of product master data and compliance to establish standards by providing the required capabilities to define, monitor and enforce quality management system standards and regulatory requirements. This role is established to better control our Quality, & Regulatory compliance, whilst still acting in a hands-on and supporting way as characteristic for IMCD's company culture.

**Duties and responsibilities**
Responsible for all activities relating to the Good Manufacturing Practices (GMP).
Maintaining IMCD Canada Inc’s certifications to maintain the company’s.
Create and update New Product Assessments for Canadian Regulatory compliance in a timely manner.
Manage the Active Pharmaceutical Ingredients (API) program which includes product releases, correspondence with Health Canada and maintenance of the Health Canada Drug Establishment Licence (DEL) for APIs and FDF intermediates.
Assist with the implementation of Lisam, the new SDS and labelling system.
Provide support when SDS revisions are made by the supplier, update internal SDS and the ERP.
Maintain and improve knowledge of WHMIS, TDG, CEPA and NFPA criteria for meeting the Canadian Health, Safety and Environment requirements for importation, handling, transporting, and sales and use of our products.
Write Standard Operating Procedures as needed.
Ensure full compliance with the company’s Health & Safety policies and procedures.
Report all hazards to ensure a safe and healthy workplace environment is maintained.
Establishing and communicating objectives for internal follow-ups
Performing a preliminary assessment of suppliers before contracting products or services with them.
Assist with maintenance of product quality and safety by providing technical information and identifying and implementing process improvements as required. Answer inquiries regarding feed, food and pharmaceutical products for principals and customers. Be a primary contact for the CFIA/Health Canada/FDA for these areas.
Conduct Internal Audits and follow schedule to ensure compliance to support all systems including AIB, ISO9001, ISO14001, FSSC 22000 and CACD RDC and others as relevant.
Ensure all non-conformances are addressed and verification activities have been completed.
Support the Principal Risk Assessment and Supplier Evaluation & Monitoring program.
Manage and provide oversight on the IMCD recall process working with all departments including liaising with the legal department and Senior Leadership providing accurate information on the impact of any potential or physical recall.
Keep current on legislation and regulatory requirements, as they relate to our products. Communicate potential impacts of new legislation or regulatory requirements to the organization.
Review and provide input with regards to determination of disposition for non-conforming material. Track and resolve cases in Salesforce, including complaints and internal corrective action requests, using root cause an

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