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    Sr. Specialist, In-Market Quality Indonesia

    Organon
    5+ years
    Not Disclosed
    Jakarta
    10 Nov. 24, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

    The job description you’ve shared is for a Quality Assurance Manager position in Indonesia with Organon. The role specifically focuses on In-Market Quality and acts as the Quality Responsible Person (QRP) and Responsible Pharmacist for the Extended Warehouse. The role involves ensuring compliance with Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP) within the scope of the company’s operations in Indonesia. Here's a detailed breakdown:

    Position Overview:

    • Role: Quality Responsible Person (QRP) and Responsible Pharmacist for the extended warehouse in Indonesia.
    • Reports to: AP In-Market Quality Sub Cluster Lead (SG/ID/VN/HK).
    • Focus: Ensuring compliance with regulatory requirements, overseeing quality systems, and managing the warehousing and distribution processes for medicinal products and medical devices.

    Key Responsibilities:

    1. Quality Systems Management:

      • Develop and maintain Quality Management Systems (QMS) to ensure compliance with GDP/GMP standards.
      • Deploy new or revised QMS policies, standards, and global SOPs, particularly for medicinal products and medical devices.
      • Collaborate with other functions such as Regulatory Affairs, Pharmacovigilance, and Supply Chain to maintain quality and compliance.

    2. Operational Oversight:

      • Manage warehousing, distribution, product release, and inventory management processes.
      • Oversee daily operations to ensure that products meet quality standards and are distributed effectively.
      • Establish performance management processes to monitor and improve quality compliance.

    3. Regulatory and Compliance Coordination:

      • Serve as the primary liaison with Health Authorities (HA) for communication and reporting notifications.
      • Ensure market actions and recall executions are properly coordinated and managed.
      • Lead internal audits, self-inspections, and Organon global quality audits.
      • Develop strategies for permanent inspection readiness.

    4. Complaint Handling & Investigation:

      • Oversee and manage customer complaint handling in the market, including trend analysis and corrective actions.

    5. External Partnerships:

      • Act as the Responsible Pharmacist, ensuring compliance with both Organon and local regulatory requirements.
      • Lead customer qualification processes, including audits and the maintenance of customer relationships.

    6. Leadership and Collaboration:

      • Provide leadership for significant investigations and fact-finding activities.
      • Collaborate with global/regional colleagues to ensure market quality management and continuous improvement.

    7. Training & Development:

      • Ensure that personnel are adequately trained in quality systems and processes.
      • Foster a culture of quality and compliance within the team.

    Required Education, Experience, and Skills:

    • Education:
      • Bachelor’s Degree in Pharmacy, Pharmaceutical Science, or a related field.
      • Completed Professional Degree in Pharmacy (local pharmacist license required).
    • Experience:
      • At least 5 years of experience in a Quality role, particularly within the pharmaceutical industry.
      • Strong knowledge of global cGDPs/cGMPs relevant to Marketing Authorization Holders.
      • Hands-on experience with SAP and data-driven decision-making.
    • Skills:
      • Strong compliance mindset and problem-solving skills.
      • Excellent leadership, project management, and organizational skills.
      • Proven ability to work in a matrix environment and across teams.
      • Fluency in Indonesian and business-level English.

    Additional Information:

    • Employee Status: Regular, full-time position.
    • Relocation: No relocation assistance.
    • VISA Sponsorship: Not offered.
    • Travel: Travel requirements unspecified but may involve visits to health authorities and key stakeholders.
    • Flexible Work: Potentially available depending on operational requirements.

    About Organon:

    • Organon is a global healthcare company focused on improving health outcomes, particularly for women and their families. Their portfolio includes solutions for Women's Health, biosimilars, and other health products that benefit communities globally.

    If you're interested in applying or need more information regarding the application process, let me know! I can also help with tailoring a resume or cover letter if you'd like.

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