Regulatory Compliance Specialist
2 days ago
About Us:
Piramal Pharma Solutions is a leading global Contract Development and Manufacturing Organisation (CDMO) of advanced drug development and manufacturing solutions to the pharmaceutical industry.
We are seeking an experienced EHS Specialist to support our North American API site in Aurora, Ontario. This role will develop and maintain Environment, Health and Safety (EHS) Management Systems used at the site. They will also be responsible for the sites Industrial Hygiene (IH) programs including developing plans, planning assessments and/or coordination of activities to execute the plans. Additionally, this role will support sustainability initiatives for the site as required.
Responsibilities:
Develop and manage EHS Management Systems for the North American API site with goals of risk reduction/mitigation and continuous improvement of EHS site functions.
Establish effective programs, guidelines & procedures to be used by the site that meet regulatory requirements and align with Piramal EHS Guidelines and Standards.
Establish and maintain the EHS learning management system (LMS) in a compliant state.
Establish and drive compliance calendars for both the NA API sites.
Monitor and trend CAPAs and issue periodic reports to drive closure to meet Key Result Areas (KRAs) for on time in full (OTIF).
Lead the development and implementation of a comprehensive Industrial Hygiene (IH) plan for new and existing pharmaceutical materials, raw materials, equipment, and processes.
Plan and coordinate qualitative and quantitative exposure assessments, IH evaluations, and related environmental health studies using contemporaneous industrial hygiene sampling techniques and equipment.
Actively engage with key stakeholders across the site to advance risk assessment and risk management processes and procedures related to IH and occupational health.
Analyse and interpret IH sampling data and generate reports that are technically accurate, grammatically correct, and appropriate for the target audience.
Oversee respiratory protective equipment (RPE) programs for the API site.
Sustainability
Provide support to sustainability initiatives for the site as required.
Benefits:
- Competitive Salary: $70,000 - $90,000 per annum depending on experience
Work Environment:
Aurora, Ontario
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