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    Trainee - Quality Stability Data

    Apotex
    0-2 years
    Not Disclosed
    Mumbai
    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 Canadian-based global health company focused on producing high-quality, affordable medicines for patients worldwide. With nearly 7,200 employees across manufacturing, R&D, and commercial operations, Apotex provides medicines in more than 75 countries. The company’s portfolio includes generic, biosimilar, and specialty products, developed and sold through vertical integration. For more information, visit www.apotex.com.

    Job Summary
    Apotex is seeking a Stability Summary Report Specialist to summarize and review stability data, ensuring that the shelf lives of commercial products are supported. This role involves providing stability data to customers for product compliance files and preparing summary reports in compliance with Apotex's procedures.

    Key Responsibilities

    • Prepare Stability Summary Reports within the required compliance timeframe.
    • Ensure the accuracy and completeness of summary reports as per Apotex’s procedures.
    • Provide summary reports for special projects and product evaluations as requested by internal or external customers.
    • Review stability data from third-party affiliates for compliance.
    • Perform Stability Impact Assessments for out-of-trend results from drug product releases, following approved procedures.
    • Evaluate stability data to ensure no significant trends are developing, maintaining justification for approved shelf life.
    • Contribute to the Annual Stability Review package for the QA Product Review group during the Annual Product Quality Review (APQR).
    • Notify the Assistant Manager of any adverse trends detected.
    • Collaborate effectively with team members to meet department goals and share knowledge.
    • Maintain compliance with health and safety standards, GMP, GDP, and regulatory requirements.
    • Demonstrate Apotex’s core values of Courage, Collaboration, Passion, and Perseverance.
    • Ensure adherence to compliance programs, including global business ethics, quality policies, safety, environment policies, and HR policies.

    Job Requirements
    Education

    • Master’s Degree in Science or Pharmacy.

    Experience and Skills

    • Strong understanding of pharmaceutical Quality Control systems.
    • In-depth knowledge of stability requirements.
    • Good interpersonal skills and a results-oriented team player.
    • Ability to work independently with minimal supervision.
    • Ability to communicate findings and escalate critical issues to the Assistant Manager.
    • Experience in working with intra/inter-departmental teams to meet business and quality goals.
    • Proficient written and verbal communication skills.
    • Familiarity with Microsoft Office applications is an added advantage.

    At Apotex, we are committed to fostering an inclusive and accessible work environment where all employees feel valued, respected, and supported. We offer accommodations for applicants with disabilities during the recruitment process. Please inform us if you require accommodations when contacted for an interview or testing.

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