Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations. Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc.
Post : Executive, Toxicology
Job Description
• Conducts Health Hazard Assessments in a timely manner upon request with a high level of autonomy.
• Actively conducts risk assessment activities for a variety of situations from a toxicological perspective when needed.
• Establishes acceptable and/or tolerable daily intakes for substances in question through review or calculations.
• Identifies No Observed Effect Levels (NOEL) and No Observed Adverse Effect Levels (NOAEL), Lethal Dose 50 (LD50) etc.
• Generates reports with a toxicological conclusion for the assessment in question based on the literature, the circumstances and the results of studies, if undertaken, based on sound toxicological science.
• Supports Safety, Health and Environment with toxicological assessments when requested.
• Supports business units in GRDQ such as Global Project Management, Quality Assurance, Formulation Development, Analytical Operations etc. bringing toxicological expertise to bear.
• Ensures good regulatory compliance.
• Functions as the Subject Matter Expert for toxicological sciences for the global organization.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.
Candidate Profile
• Master of Pharmacy in Pharmacology, M. Pharm,
• Bachelor of Pharmacy, B. Pharm
• General and Regulatory toxicology, Risk characterization, Safety assessment, Consumer products, Good Laboratory Practice, as a toxicologist in the area of drug development.
• Good knowledge and skill in toxicological testing procedures for pesticides, new chemical entities, IND requirements.
• Good knowledge and skill in risk assessment procedures for Medical products/Medical devices.
• >5 years of experience in Toxicology CRO and Pharmaceutical industries.
Additional Information
Experience : >5 years of experience
Qualification : B.Pharm, M.Pharm
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 25th October 2024
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