Quality Executive Job at Apotex Inc – Pharma Apply Online

Quality Executive Job at Apotex Inc – Pharma Apply Online

Executive, Quality – APQR

Date: Oct 21, 2024

Location: Mumbai, MH, IN, 400079

Company: Apotex

About Apotex Inc.:

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the

Apotex group is focused on the development and sale of generic, biosimilar, and specialty products.

For more information visit: www.apotex.com.

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 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.
• Coordinate with Project Leader(s) – QA Product Review / Manager for project completion.
• Compile the APQRs within required timelines to ensure adequate time for approvals.
• Respond to Project Leader’s queries for APQR summary reports as required.
• Assist in the 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.
• Work in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate behaviors that exhibit our organizational values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence to all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• Perform 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, and process efficiency.
• Expert knowledge of SAP transactions used to support the Product Review process.
• Ensure timely communication of findings to 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, 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.