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Urgent! Senior Associate QA, Global Distribution Quality (GDQ) Job Opening In India, India – Now Hiring Confidential

Senior Associate QA, Global Distribution Quality (GDQ)



Job description

Position Overview:

Working independently, the Quality Assurance (QA) Contact will be responsible for ensuring compliance with GMP/GDP and performing various QA-related activities, including overseeing quality events, change control records, corrective and preventive actions, and distribution complaints.

The role will also include collaboration with third-party vendors to ensure service level alignment, support for logistics providers, and participation in audits and inspections.

Key Responsibilities:

  • Quality Event & Change Control:
  • Perform the QA Contact role on Quality Events, Change Control records, Corrective and Preventive Actions (CAPAs), and QA triage of Distribution complaints to ensure compliance with regulations.
  • End-to-End Process Compliance:
  • Work closely with all relevant partners for the end-to-end process and ensure full compliance with GMP (Good Manufacturing Practices) and GDP (Good Distribution Practices).
  • Subject Matter Expert (SME):
  • Act as a subject matter expert for transportation-related Quality Processes, providing technical and procedural expertise to internal teams.
  • 3rd Party Collaboration:
  • Collaborate with 3rd parties (e.g., logistics and transportation service providers) to ensure alignment with service levels and to identify opportunities for performance improvement.
  • SOP & Documentation Compliance:
  • Prepare, review, and approve Standard Operating Procedures (SOPs) and other GMP/GDP documentation, ensuring compliance with corporate, regulatory, and Good Manufacturing Practices (cGMP) requirements.
  • Risk Management:
  • Understand and incorporate risk management strategies into the overall supply chain strategy to mitigate potential risks.
  • Provider Oversight:
  • Provide support for logistics service providers and transportation service providers by overseeing their performance and ensuring service compliance.
  • Audit & Inspection Support:
  • Support internal/external audits and inspections as part of the audit/inspection team, ensuring adherence to regulatory standards.
  • Quality Expertise:
  • Provide quality expertise and guidance to operational staff and cross-functional teams within Amgen.
  • Operational Improvement:
  • Take part in operational improvement initiatives, programs, and projects aimed at enhancing efficiency and compliance.
  • Supplier Relationship Management:
  • Oversee supplier metrics, conduct performance assessments, and manage key documents to maintain strong supplier relationships and identify improvement opportunities.
  • Independent Work & Leadership:
  • Work with minimal supervision, demonstrating leadership in line with Amgen Values and Leadership Attributes.

Qualifications:

Basic Qualifications & Experience:

  • Bachelor's degree in Science or Engineering and 2+ years of professional experience in related fields.
  • Understanding of GMP/GDP requirements and their application in pharmaceutical logistics.
  • Familiarity with logistics processes for parcel, transport, and warehousing providers.
  • Experience in Validation/Qualification of processes, equipment, and facilities.
  • Strong technical writing skills, with experience drafting and reviewing documentation.
  • Independent, self-starter with the ability to work autonomously under pressure and within teams.
  • Knowledge of GMP/GDP and pharmaceutical regulations.
  • Energetic, detail-oriented, and highly motivated with a 'can do' attitude.
  • Strong change management skills.
  • Effective communication skills across all levels of the organization.
  • Proficiency with Microsoft Office Tools (Excel, Word, PowerPoint).
  • Ability to multi-task and prioritize effectively in a dynamic environment.

What You Can Expect from Us:

At Amgen, we are dedicated to supporting your professional and personal growth, and well-being.

As part of our commitment to developing treatments that care for others, we also prioritize your journey every step of the way.

We offer:

  • Competitive benefits package to support your health and well-being.
  • A collaborative culture that encourages continuous learning and career development.
  • Opportunities for professional growth within a leading biopharmaceutical company.

Skills Required
Documentation, Change Management, External Audit, Data Validation, Inspection


Required Skill Profession

Business Operations Specialists



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