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    Lead Exec - Gbs-Emq

    Apotex
    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 leading Canadian-based global health company committed to producing high-quality, affordable medicines for patients worldwide. With nearly 7,200 employees across manufacturing, R&D, and commercial operations, Apotex provides medicines in over 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 is seeking a Quality Assurance Specialist for Third Party Operations to ensure compliance with regulatory and GMP obligations for products manufactured by Third Parties and those supplied by Apotex to Third Party Organizations. This role involves managing customer complaints, supporting the Annual Product Quality Review, and interacting with various internal departments, including RA, New Product Launch, Supply Chain, and Sales & Marketing.

    Key Responsibilities

    • Handle customer complaints for Third Party manufactured products according to the established complaint process.
    • Manage the receipt and triage of all incoming customer complaints.
    • Log complaint details in the customer complaint system and send out acknowledgment letters to complainants.
    • Notify Third-Party manufacturers of incoming complaints and track investigation progress.
    • Review Third-Party Investigation Reports to ensure complaints are thoroughly investigated and corrective actions are identified.
    • Close complaints and send out response letters to complainants.
    • Escalate critical complaints to Global External Manufacturing Quality immediately if new information or investigation outcomes reveal critical issues.
    • Review the final Annual Product Review (APR) using vendor and Apotex’s APR, submitting it to the Manager in Canada for approval.
    • Assist in developing processes for Product Compliance File assessments and gap closure.
    • Provide support to Regulatory Affairs and Corporate Quality on internal requests for information held at Third Party Manufacturers.
    • Contribute to the development of SOPs for efficient and compliant External Quality functions.
    • Coordinate a centralized documentation control system for External Quality and manage the routing, review, issuance, and archiving of controlled documents.
    • Maintain and update the External Quality database for Third Party Manufacturers.
    • Work in a collaborative, safe manner to achieve team goals while adhering to Apotex’s organizational values of Collaboration, Courage, Perseverance, and Passion.
    • Ensure adherence to compliance programs, including the Global Business Ethics and Compliance Program, Global Quality policies, Safety and Environment policies, and HR policies.

    Job Requirements
    Education

    • Bachelor’s degree in Science, Pharmaceutical Technology, or a related field.

    Experience and Skills

    • Strong knowledge of global cGMPs (HC, FDA, and EU) and QA/QC systems for the manufacture of human drug products.
    • Detail-oriented with high accuracy and reliability.
    • Ability to manage multiple priorities in a fast-paced environment.
    • Superior organizational, analytical, and communication skills.
    • Ability to work independently or as part of a team.
    • Strong relationship-building skills with Third Party partners.
    • Demonstrates leadership and accountability.
    • At least 5-6 years of progressive Quality experience in QA or QA/QC roles.
    • Proficiency with Microsoft Office Suite (Word, Excel, Access, PowerPoint).
    • Experience with SAP and TrackWise is an asset.

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

     

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