Coordinator, Ext Quality

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 Responsibilities

• 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.
• Shift timing - 8 hour 8am -4am (Monday - Friday)

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