Technician, QAIP Mfg QS6-GQC-IPSP S

Job Summary

Provide Quality support and oversight of manufacturing areas to ensure compliance with Apotex Quality Systems requirements and Good Manufacturing Practices.

Responsible for review and verification of all Master Manufacturing Records to ensure completeness and accuracy as per established Apotex and GMP standards. 

Responsible for transaction verification and result recording in SAP and LIMS to allow for batch disposition from QA In Process (QAIP) to QA Product Release.

Job Responsibilities

• Review all Master Manufacturing Records to ensure quality products are manufactured according to established standards and procedures.
• Performs verification of potency calculation in Master Manufacturing Record as required.
• Performs results recording in SAP and LIMS where applicable.
• Provides recommendations for quality issues identified and the appropriateness of action(s) taken for resolution in relation to Master Manufacturing Record issues.
• Responsible to initiate Shelf Life Extension (SLED) requests and completion of F-notification reports related to process yield. Ensure that all F notifications are clearly and appropriately documented in order to make products disposition decision according to Apotex established standards.
• Track status of outstanding investigations (PRs)/F-notifications to ensure that batches are being processed through Supply Chain in a timely manner.
• Acts as a backup to QAIP Manufacturing Technician (QS5) and is able to perform all required duties of QAIP Manufacturing Technician (QS5).
• Supports Supervisor in training of new hires.
• 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.
• All other relevant duties as assigned.

Job Requirements

• Education: A college diploma/university degree in Pharmaceutical Technology/ Chemistry or related sciences
  
  
• Knowledge, Skills and Abilities:
  • A good command of the English language, both written and verbal
  • Excellent organizational skills and the ability to manage time effectively
  • Ability to follow instructions according to written procedures
  • Ability to manage multiple priorities in a fast-paced and changing environment
  • A knowledge of GMP is required
  • Familiarity with Word, Excel, Access is an asset

• Experience:
  • 2-3 years of relevant working experience in pharmaceutical industry