Job Summary

Responsible for reviewing and approving deviation investigational reports at the site level for Apotex OLD to ensure that investigations are conducted in a timely and efficient manner leading to root cause elucidation. Accountable to ensure that established procedures on how to report and investigate deviations using validated electronic system and appropriate corrective actions / preventative actions (CAPA) are identified and implemented.

Acts as senior QA Approver for complex investigations with impact to the multiple products and or batches and provides background, prepares presentations with recommendations to support risk assessment decisions to Site Senior Management.

Job Responsibilities

• Oversees and acts as Quality Approver and SME for Apotex OLD deviations (Production, Production Technical, In-process, Customer Complaints and QC laboratory failures) at a site level and ensures investigations are initiated following existing procedure.
• Acts as resource providing support & guidance to QA Approvers and Lead Investigators.
• Assists with assignment of the work to Project Leaders, QA Approvers and provides guidance with complex investigations impacting multiple batches and/or products.
• Provides QA approval to allow production to proceed with manufacturing based upon preliminary investigation findings and root cause analysis provided all the necessary adjustments have been made to restore equipment/facilities to full operation.
• Liaises with internal customers and stake holders to review and discuss deviation root causes and proposed CAPAs for complex investigations and provides QA recommendations regarding actions such as blocking of Master Formula or initiating process optimization investigations with Technical Operations or Analytical Operations.
• Provides training to new Project Leaders.
• Fosters positive and creative team environment built on mutual trust and respect while monitoring individual performance and contribution on an on-going basis and providing regular updates to Associate Director and relevant department members.
• Provides direction, reviews and approves relevant sections of investigations drafted by Lead Investigators.
• Ensures adherence to deviation investigation proces and timelines, including determining true root cause and appropriate CAPAs, and extensions
• Approves Production and Production Technical, In-process Customer Complaints and QC laboratory incidents or deviations in validated electronic system at a site level for Apotex OLD.
• Revises existing procedures as necessary.

(Customer Complaints & Stability, QA Approval)

• Participate in escalation of failures to Corporate QA

(QC Laboratory, QA Approval)

• Participates in QC Laboratory Investigation reports (LIR) to ensure investigations are initiated in timely manner, Review LIRs for accuracy & completeness along with approving including Phase 2 Testing plans & Hypotheses.
• Reviews and approves Method Validation Protocols, Method Validation Reports, Certificates of Technology Transfer and Method Verification Reports.
• Reviews and assesses QC Laboratory change controls and approve QC specifications in LIMS

(Master Document Change Control Assessment, QA Approval)

• Assists in Change Control assessments and approvals of Master document updates

General:

• Works in a safe manner and collaborates as a team member to achieve all outcomes.
• Demonstrates Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensures personal adherence with all compliance programs including the Industry Regulations, 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
  • Bachelors degree in science
  • College diploma in science, in conjuction with a minimum of 5 years relevant experience in the pharmaceutical industry
• Knowledge, Skills and Abilities
  • Superior organizational, interpersonal and communication skills
  • Ability to work independently and manage multiple priorities in a fast-paced and changing environment
  • Good command of the English language, both written and verbal
  • Proficiency with Microsoft Office (especially Word & Excel), Trackwise and SAP
  • Knowledge of GMP and fluency in RCCA tools
• Experience
  • 3 to 5 years experience in the pharmaceutical industry
  • 3 years of past supervisory/leadership experience strongly preferred

Experience in project management is an asset