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Senior Analyst - Quality - Apqr

2-4 years
Not Disclosed
10 Nov. 15, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

About Apotex Inc.
Apotex Inc. is a global health company based in Canada, dedicated to providing high-quality, affordable medicines to patients worldwide. With nearly 7,200 employees across manufacturing, R&D, and commercial operations, Apotex’s medicines are accessible in more than 75 countries. The company focuses on the development and sale of generic, biosimilar, and specialty products through vertical integration. For more information, visit www.apotex.com.

Job Summary
Apotex Research Private Limited is seeking a skilled professional to compile Annual Product Quality Reviews (APQRs) in accordance with applicable SOPs. The role involves analyzing and summarizing product review data in a timely and accurate manner, ensuring that all necessary reviews are performed and reported in compliance with GMP and regulatory standards.

Key Responsibilities

  • Compile APQRs per SOP, covering topics such as manufacturing processes, API/Excipients, changes, test methods, validation, and stability reviews.
  • Collect, analyze, and summarize data including deviations, complaints, recalls, and market commitments.
  • Ensure the APQR is completed on time and submitted for review and approval.
  • Communicate with project leaders to ensure timely completion and address queries related to APQR summary reports.
  • Assist in preparing, reviewing, and revising SOPs as required.
  • Maintain a tracking system for APQR compilation and review.
  • Ensure compliance with GMP, SOPs, regulatory requirements, and safety standards.
  • Work independently and as part of inter-departmental teams to meet business and quality goals.
  • Demonstrate the company’s values: Collaboration, Courage, Perseverance, and Passion.
  • Adhere to all compliance programs, including global business ethics, safety, and environment policies.

Job Requirements
Education

  • B. Pharm, M. Pharm, or M.Sc. in a related field.

Experience

  • 2-4 years in the pharmaceutical industry, with a focus on Quality Assurance.

Skills

  • Strong knowledge of SAP transactions used for product review.
  • Expertise in identifying system improvement opportunities.
  • Excellent technical writing, communication, and interpersonal skills.
  • Knowledge of international regulatory requirements and cGMP.
  • Ability to work independently and as part of a team to meet deadlines and quality standards.

At Apotex, we are committed to fostering an inclusive and accessible work environment, where all employees are valued, respected, and supported. Accommodations for applicants with disabilities are available during the recruitment process.