Coordinator, QAIP

Job Summary

• Responsible for ensuring that all incoming raw materials, packaging components and packaged products are inspected and sampled in accordance with Good Manufacturing Practices and established Standard Operating Procedures
• Responsible to coordinating, with the Supervisor Logistics, training, monitoring and auditing of the receiving sampling and inspection activities performed by Samplers/Material Handlers
• Responsible to ensure that deviations or non-conformances are adequately investigated and documented in order to provide appropriate disposition of materials

Job Responsibilities

• Works in a safe manner collaborating as a team member to achieve all outcomes
• Demonstrate Behaviours 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
• Have required working knowledge to operate SAP, LIMS, and Trackwise systems

Quality Systems

• Lead investigations and CAPA implementations within the QAIP department and provide support to investigations and implementation of CAPAs to all areas of the business as required
• Review and approve all non-conformances and assist Logistics personnel with troubleshooting/investigating issues related to material receiving process, sampling process and NIR or TruScan analysis as required and work as a team member to achieve all tasks/activities required to adequately investigate and address the non-conformances and prevent reoccurrence
• Generate investigations as an observing department when deviations from established procedures or acceptance criteria are observed

Quality Support

• Audit the work performed by Samplers/Material Handlers during receipt and inspection of incoming material, sampling of material and completion of NIR or TruScan analysis
• Review logistics receiving / sampling and Production documents
• Review and update the manufacturing plant entry in SAP in accordance with manufacturer Certificate of Analysis
• Notify Supplier Quality/Procurement departments to update SAP Master Data (i.e. Material Storage Condition) when discrepancy is observed during material receiving process

QAIP Support Activities

• Oversees the daily operations of the QAIP Sampling area and Production to ensure rooms and equipment, are used in accordance with GMP and Standard Operating Procedures
• Performs reserve sample inspections and waste disposal as required
• Log in samples into SAP/LIMS and forward the documents/material samples to required labs for testing
• Initiate Change Control for changes related to QAIP process as required
• Ensure that training records are accurate and completed according to cGMP
• Provides training to new Coordinators
• All other relevant duties as assigned.

Job Requirements

• Education
  • Bachelor of Science Degree from a recognized educational institution in a related field or Community College diploma in a related field
• Knowledge, Skills and Abilities
  • Must be familiar and knowledgeable with GMP and quality requirements
  • Excellent English written and verbal communication skills
  • Good organizational skills and ability to manage time effectively
  • Must be detail-oriented, accurate and reliable
  • Must be able to work independently with minimal supervision
  • Proven analytical and problem solving skills
  • Ability to manage multiple priorities in a fast-paced and changing environment
  • Familiarity with Word, Excel, Access would be an asset
• Experience
  • Minimum one year of relevant experience in a pharmaceutical environment with a Bachelor of Science Degree
  • Minimum of three years of relevant experience in a pharmaceutical environment with a Community College Diploma