Coordinator, External Quality

at  Apotex Inc

ABOUT APOTEX INC.

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.
For more information visit: www.apotex.com.

JOB SUMMARY

Provide support for quality activities within the External Manufacturing Quality Department including retain sample management program, product release documentation management and coordinating follow-up, receipt, logging and shipment of customer complaint samples.

JOB REQUIREMENTS

• Education
• Post-secondary education in Business or Science, Administrative or equivalent work-related experience preferred.
• 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
• Familiarity with MS Word, Excel and Access is an asset
• Experience
• Three to five years of experience in a pharmaceutical environment
  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.
  **For any inquires on this posting please contact: nghegadm@apotex.co.i

• Coordinate and perform activities related to reconciliation, inspection and disposal of reserve/retain samples for third party products.
• Coordinate, compile and review documentation to support release of third party products.
• Conduct follow-ups, receives/logs and coordinates shipment of complaint samples for third party products.
• Assist in follow up with Third Party Organizations (TPOs) for documentation, protocols/reports, change controls, deviations and other documents required for Product Compliance File (PCF) to support product launch and product/batch disposition.
• Interacts with external TPOs and internal functional groups for obtaining the required documentation to support product launch and product disposition.
• Organizes the management of the departmental controlled documents.
• Create and perform follow-up on change control records dealing with third party products and departmental controlled documents.
• Participate in creation and updating of departmental procedures.
• Participate and provide support in compilation of data/information to support departmental objectives/projects.
• Performs all work in accordance with all established procedures, regulatory and compliance and safety requirements.
• Performs all work in support of Apotex’s Values of Collaboration, Courage, Perseverance and Passion.
• Works as a member of a team to achieve all outcomes.
• Other duties as assigned.