Trainee, GBS-EMQ-GBS-EMQ G

Job Summary

Responsible for managing the Quality Product Compliance files for Canada and the U.S. Additionally, acts as the primary Quality contact for products which Apotex acts as a contract manufacturer.
Acts as liaison between Apotex’s manufacturing sites and customer affiliates.

Job Responsibilities

• Maintain Quality Product Compliance files for all 3rd party contract manufactured product in which Apotex is the Marketing Authorization holder or acts as a distributor for the Canadian market; this includes formally requesting annually with our vendors their current approved master documentation, stability summary reports. Follows up with vendors to ensure all documents are received.
• Develops and maintains Quality Product Compliance files for the US marketplace based on current GMP Regulations.
• Perform assigned Post implementation tasks from TrackWise.
• Initiate the Change Controls in TrackWise, where no RA assessment required.
• Tracking of confirmatory testing & batch record review (Initial launch batches and annual batches).
• Request and obtain vendor APRs as per the schedule on time.
• Maintain and track unique identifier documentation and expiry and ensure up to date.
• Acts as the liaison between external customers and our internal functional groups to provide customer quality requests in a timely manner.
• Interacts with internal functional groups including stability, quality assurance, quality control, regulatory affairs, and quality compliance for obtaining the necessary documentation and handling customer requests.
• Tracks open requests from customers to ensure timely responses. Escalate to senior management any significant delays.
• Responsible for timely compilation of batch release documents under guidance of Global External Manufacturing Quality.
• Responsible for timely updation of batch release tracker associated with batch release activity.
• Coordinate with third party manufacturing sites and internal stakeholders for obtaining required documents for release of batches in US and Canada market.
• Escalate any non-conformance/delay associated with batch release documents compilation to Global Batch Release team.
• Assist External Manufacturing Quality with follow up for new product launch, change control or deviations.
• Performs all work in accordance with all established regulatory and compliance and safety requirements.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviors 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
  • 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 focused.
  • 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
  • One to two years of experience in a pharmaceutical environment.
  • Familiarity with MS Word, Excel and Access is an asset.