Senior Analyst - Batch Record Review

Sr. Analyst - Batch Record Review

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

For more information visit: www.apotex.com.

 

Job Summary

Responsible for Compilation of batch documents for release of batches to Canada and U.S markets.  In addition to this EMQ tracker updation, follow up with traffic & logistic team, manufacturing sites etc.

Job Responsibilities

1. Responsible for timely Compilation of Batch Release Documents for all third-party contract manufactured products for which Company is the Marketing Authorization holder or acts as a distributor for the release of products to Canadian /US market.
2. Responsible for timely updation of batch release tracker associated with batch release activity.
3. Coordinate with third party manufacturing sites and internal stakeholders for obtaining required documents for release of batches in US and Canada market.
4. Escalate any non-conformance/delay associated with batch release documents compilation to Global Batch Release team.
5. Ensure that documents are in full compliance with GMP, and regulatory standards.
6. Performs all work in accordance with all established regulatory and compliance and safety requirements.
7. Works in a safe manner collaborating as a team member to achieve all outcomes.
8. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
9. 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.
10. All other relevant duties as assigned.

Responsabilités inhérentes à l’emploi

Job Requirements

• Education
  • Bachelor of Science Degree/Community College Diploma (or equivalent) in a related discipline.
• Knowledge, Skills and Abilities
  • Effective in communicating (speak, read and write) in English
  • Excellent organizational skills and the ability to manage time effectively
  • Strong interpersonal skills and very customer focussed
  • Must be detail-oriented, accurate and reliable
  • Must be able to work independently with minimal supervision
  • Ability to follow instructions according to written procedures
  • Ability to manage multiple priorities in a fast-paced and changing environment
  • Knowledge of GMP and regulatory requirements
• Experience
  • Two to five years of experience in a pharmaceutical environment
  • Familiarity with MS Word, Excel and Access is an asset

 

Exigences liées au poste

At Apotex, we are committed to fostering a welcoming and accessible work environment, where all everyone feels valued, respected, and supported to succeed. 

We offer 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.

 

Experience Level

Senior Level