Senior Associate QA, Global Distribution Quality - Hyderabad / Secunderabad, Telangana - Amgen Technology Private Limited

    Amgen Technology Private Limited
    Amgen Technology Private Limited Hyderabad / Secunderabad, Telangana

    1 day ago

    Full time
    Description

    We are seeking a highly motivated individual to join our Global Distribution Quality (GDQ) team as a Senior Associate QA. This is an exciting opportunity to join a team of quality professionals who oversee global product distribution and transportation. The ideal candidate will be a subject matter expert in transportation-related Quality Processes and will provide QA oversight for Global Supply Chain operations. You will be responsible for ensuring compliance with GMP/GDP regulations, collaborating with third-party logistics providers, and driving continuous improvement initiatives.

    Roles & Responsibilities

    • Quality Oversight & Compliance: Act as the QA Contact for Quality Events, Change Control, CAPA, and Distribution complaints. You will work closely with all relevant collaborators to ensure end-to-end process compliance with GMP/GDP regulations.
    • Process Management: Act as a subject matter expert (SME) for transportation-related Quality Processes. You will prepare, review, and approve SOPs and other GMP/GDP documentation to ensure alignment with corporate and regulatory requirements.
    • Third-Party Collaboration: Collaborate with third parties to ensure adherence to service levels and identify opportunities for performance improvement. You will also provide support for logistic and transportation service provider oversight.
    • Risk Management & Audits: Understand and incorporate risk management strategies into the overall supply chain strategy. You will support tactical activities for internal and external audits and inspections.
    • Continuous Improvement: Take part in operational improvement initiatives, programs, and projects. You will also own supplier metrics and performance assessments to inform the health of supplier relationships.

    Technical Skills

    • Strong understanding of GMP/GDP requirements and pharmaceutical regulations.
    • Familiarity with logistics processes for parcel, transport, and warehousing providers.
    • Experience in Validation/Qualification of processes, equipment, and facilities.
    • Strong technical writing skills.
    • Experience with Microsoft Office Tools, including Excel, Word, and PowerPoint.

    Qualifications

    • A Bachelor's degree in science or engineering with professional experience in related fields.
    • Strong continuous improvement attitude and lean practices experience is preferred.
    • Understanding of end-to-end supply chain business processes is a plus.
    • Experience in project management across multiple departments and geographies is preferred.

    Soft Skills

    • Problem-Solving: Strong analytical and problem-solving skills, with a quick process understanding and insight.
    • Communication: Effective written and verbal communication skills, with the ability to communicate across all levels of the organization.
    • Proactiveness: Independent self-starter, able to work autonomously, under pressure, and as part of a team.
    • Attention to Detail: Energetic, detail-oriented, and highly motivated with a 'can-do' outlook.
    • Adaptability: Possesses strong change management skills and the ability to multi-task and prioritize effectively. This role may require working in shifts or extended hours.

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