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    Senior Manager, Qa(Compliance & Risk Mgt)

    Apotex
    15+ years
    Not Disclosed
    Bangalore
    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 headquartered in Canada, committed to producing high-quality, affordable medicines for patients worldwide. With nearly 7,200 employees across manufacturing, R&D, and commercial operations, Apotex’s medicines are accessible in over 75 countries. Focused on generic, biosimilar, and specialty products, the company strives for innovation through vertical integration. For more details, visit: www.apotex.com.

    Job Summary
    Apotex Research Private Limited is seeking a Senior Manager within Compliance & Risk Management. This role involves managing various compliance activities including Product Recalls, Field Alert Reports, Quality Performance Indicators (QPIs), Inspection Management, CAPAs, and handling market complaints. The Senior Manager will oversee internal audit management, supplier quality, and quality compliance systems to ensure the highest standards of quality and risk management.

    Key Responsibilities

    • Manage subordinates, providing necessary training, tools, and resources in line with regulatory requirements.
    • Resolve CAPA issues and collaborate with other departments to enhance quality systems.
    • Serve as a Super User for QMS Track Wise Change control.
    • Lead Internal and Supplier Audits, ensuring compliance with post-marketing activities like recalls, FARs, and market complaints.
    • Act as a certified trainer for QMS Track Wise and GMP Modules at ARPL.
    • Lead remediation action plans and co-ordinate global market actions, recalls, and regulatory reporting.
    • Plan staffing and budget needs, set goals for compliance, and develop team members.
    • Perform GMP rounds and ensure state of compliance within ARPL.
    • Provide regulatory guidance to internal and external stakeholders and stay updated on regulatory trends.

    Job Requirements
    Education

    • Master’s degree in Chemistry or Pharmacy.

    Experience

    • 15+ years of experience in a GMP-regulated industry.

    Skills

    • Strong leadership and interpersonal skills.
    • Expertise in Trackwise, SAP, Livelink, and CAPA implementation.
    • Experience in performing Supplier Audits and reviewing APQRs.
    • Proven technical and problem-solving skills in quality management systems.

    At Apotex, we are committed to creating an inclusive work environment. Accommodations for applicants with disabilities are available during the recruitment process.

     

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