Executive, GBS Quality APQR-GBS-APQR G

ApoPharma, a member of the Apotex group of companies, is a pharmaceutical company devoted to the discovery, development and provision of new medicines to help improve the quality of life of patients with debilitating and life-threatening diseases. Investigation into the pathological role of iron in human disease, and how to use novel medicines to treat conditions created or worsened by iron, is a major research focus of ApoPharma.

Job Summary

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

Job Responsibilities

• Perform Annual Product Quality Reviews (APQRs) compilation as assigned. This includes the following at minimum, as per SOP:
• 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 / WI’s.
• 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.
• Co-ordinate 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.
• Responses 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.
• 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
• B. Pharm/ M. Pharm/ M.Sc
• Knowledge, Skills and Abilities
• Identify system improvement opportunities for data gathering, template content/format, process efficiency.
• Expert knowledge of SAP transactions used to support the Product Review process.
• Ensure timely communication of findings to the key business areas.
• Maintain the tracking system for compilation and review of assigned APQRs.
• Ensure that the annual product reviews are performed in full compliance with current procedures.
• Expert knowledge of International regulatory requirements that apply to Product Reviews.
• Ensure that all work is performed in compliance with GMP, SOPs, regulatory requirements and established safety standards.
• Demonstrated cGMP knowledge.
• Excellent technical writing, communication skills and interpersonal skills.
• 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.
• Experience
• Minimum 3-6 years in the pharmaceutical industry with an emphasis on Quality Assurance.
  

At ApoPharma, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. ApoPharma offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.