About the Company
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas – Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. We are committed to pushing the boundaries of science to deliver life-changing medicines. Our Canadian headquarters in Mississauga, Ontario, plays a vital role in our global mission.
Job Description
We are seeking a highly motivated and detail-oriented Food & Drug Administration (FDA) Compliance Intern to join our Quality Assurance team. This internship offers an invaluable opportunity to gain hands-on experience in regulatory compliance within the pharmaceutical industry. The intern will support various aspects of FDA and Health Canada regulations, ensuring our products meet the highest standards of safety and efficacy. This role is ideal for students or recent graduates eager to learn about regulatory affairs and quality systems in a fast-paced corporate environment. You will work closely with experienced professionals and contribute to projects that directly impact patient health.
Key Responsibilities
- Assist with the review and maintenance of regulatory documentation and submissions.
- Support internal audits and prepare for external inspections related to FDA and Health Canada compliance.
- Research and interpret FDA guidelines, Health Canada regulations, and industry best practices.
- Contribute to the development and revision of Standard Operating Procedures (SOPs) related to compliance.
- Help track and manage corrective and preventive actions (CAPAs) and quality events.
- Participate in cross-functional team meetings to discuss compliance-related issues and strategies.
- Compile data and generate reports for compliance metrics and trends.
- Support training initiatives on regulatory requirements for relevant departments.
Required Skills
- Currently pursuing or recently completed a Bachelor's degree in a scientific field (e.g., Pharmacy, Chemistry, Biology, Regulatory Affairs, or a related discipline).
- Strong analytical and problem-solving skills.
- Excellent written and verbal communication abilities.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- High level of attention to detail and accuracy.
- Ability to work independently and as part of a team.
- Eagerness to learn about pharmaceutical regulations and quality systems.
Preferred Qualifications
- Basic understanding of pharmaceutical development and manufacturing processes.
- Familiarity with regulatory frameworks such as FDA cGMP, ICH guidelines, or Health Canada regulations.
- Previous experience with documentation management systems.
Perks & Benefits
- Competitive hourly wage.
- Opportunity to work on impactful projects.
- Mentorship from industry experts.
- Exposure to a global pharmaceutical company's operations.
- Networking opportunities within the industry.
- Professional development workshops and training.
- Modern office environment with amenities.
How to Apply
If you are interested in this position, please click the "Apply Now" button below. To ensure your application is properly considered, please prepare the following:
- An up-to-date Resume or CV
- A brief cover letter summarizing your experience and motivation
Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted for an interview.
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