WhatsApp Group Join Now
Telegram Group Join Now

ad
AD
Centered Ad Example

Job highlights

Work/Life Balance

Time management

challenging projects

Insurance

Job Summary:

  • Compile annual product quality reviews (APQRs) per applicable SOPs.
  • Collect, analyze, and summarize product review data correctly and completely in a timely manner.

Job Responsibilities:

  • Perform Annual Product Quality Reviews (APQRs) compilation as per SOP, including:
    • Manufacturing Process Overview
    • Batches Released / Rejected
    • APIs, Excipients
    • Changes
    • Test Method and Specification
    • Manufacturing / Process Validation, Equipment, and Utilities Qualification
    • Sterility Validation / Qualification (if applicable)
    • Packaging Component Deviations/Changes
    • Compendial Review
    • Deviations
    • Critical In-Process Attributes
    • Analytical Test Results
    • Recalls and Field Alerts, Returns
    • Retention Samples Review
    • Technical Agreements (as appropriate)
    • Marketing Authorizations Variations and Post Market Commitments (as appropriate)
    • Complaints
    • Stability
    • Conclusion and Product Rating
    • Concerns, Recommendations, and Issues for Follow-Up
  • Perform complete and correct transactions of the data as per SOP/WIs.
  • Summarize and trend analytical data from LIMS or other acceptable systems.
  • Ensure that the complete APQR is submitted for review and accepted by the Reviewer and Project Leader QA Product Review/Manager, QA Product Review.
  • Coordinate with Project Leader(s) – QA Product Review / Manager for completion of the projects.
  • Compile the APQRs within required timelines to ensure that there is adequate time for approvals.
  • Respond to Project Leader’s queries for APQR summary reports as required.
  • Assist in preparation, review, and revision of Standard Operating Procedures (SOPs) as required.
  • Ensure that all work is performed in compliance with GMP, SOPs, regulatory requirements, and established safety standards.
  • Work both independently and as part of intra/inter-departmental teams to ensure that all work is completed in a timely manner to meet both business and quality standards.
  • 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.

Application Link

ad
AD
Apotex Hiring Trainee in QA

Popup Ad Example
Sticky Buttons
Join WhatsApp Group References Join Telegram