Job Description

About Apotex Inc. 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. fully integrated global developer and manufacturer of complete transdermal solutions; Apotex Consumer Products, a division of Apotex Inc. focused on brand name products; and Global Active Pharmaceutical Ingredients (GAPI), a division of Apotex Inc. focused on the manufacturing of active pharmaceutical ingredients (API) for Apotex and third parties. For more information visit: www.apotex.com.

Job Summary

Responsible for execution of the study and system related activities as per the established Standard Operating Procedures (SOP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and regulatory requirements.

Job Responsibilities

• Conducts duties following established Apotex Research Pvt. Ltd., Bioequivalence Center\xe2\x80\x99s Standard Operating Procedures and in a manner consistent with the appropriate regulatory guidelines, GCP requirements and Safe Work Procedures.
• Entry of the study data in the required formats / data base for report table preparation and CDISC datasets preparation.
• Performs the collection, recording, retrieval of information, verify the accuracy of the information, manage data storage and retrieval systems.
• Review of report tables.
• Performs the activities related to requisition, receiving and accountability of the forms for the study.
• Ensure readiness of the department to face regulatory audit by following good documentation practices, GCP & relevant SOPs.
• Organizing files and collecting clinical data to be entered into the databases or in required formats.
• Assists in reconciliation of the study data.
• Coordinates / communicates internal and / or with cross functional departments for study relevant activities.
• Perform study activities as per the study specific protocol requirements and other duties as assigned by the Clinical Operations Management/delegate as training and experience allow.
• Responsible for handling (receiving, Issuing, Storage etc.,) of Clinical Study Materials in stores.
• Performs work in accordance with all established regulatory, compliance and safety requirements.
• 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.

Job Requirements

• Education
  • B.Pharm / Pharm D / B.Sc. in Life Science related filed.
• Knowledge, Skills and Abilities
  • Good skills in MS Office.
  • Good in Communication skills.
  • Flexible to work
• Experience
  • 0-2 years in Clinical Reasearch

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.