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325 Amgen Jobs

Senior Associate Quality Assurance - Global Supply Quality

3-5 years

Hyderabad / Secunderabad

Senior Associate Quality Assurance - Global Supply Quality

Amgen

posted 21d ago

Job Role Insights

Flexible timing

Job Description

Responsibilities:

Working independently, the individual will be responsible for, but not limited to the following:

  • Perform QA Contact role for partners to ensure adherence to quality agreements, identifying performance improvement opportunities
  • Perform Partner/Client assessments for Change Control and Deviation records
  • Perform Quality tasks in support of Partnership Alliance Quality in accordance with Quality Agreements (i.e. document revisions, document redactions, support partner audits)
  • May perform QA responsibilities associated with Portfolio Strategy Execution, such as supporting Due Diligence activities
  • Work closely with all relevant key collaborators for the end-to-end process and ensure compliance to GMP/GDP.
  • Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP) and other applicable regulations
  • Collaborate with external suppliers and partners
  • Understand and incorporate risk management strategy into the overall external supply lifecycle
  • Support in tactical activities related to internal/external audits and inspections
  • Take part in operational improvement initiatives, programs, and projects
  • Develop solutions that are thorough, practical, and consistent with functional objectives
  • Ownership of business metrics, performance assessments, and other key documents to inform the health of external supplier and partner relationships.
  • Work under minimal supervision in line with Amgen Values and Leadership Attributes.


Basic Qualifications:

  • Masters degree and 1 to 3 years of experience in related fields OR
  • Bachelors degree and 3 to 5 years of experience in related fields OR
  • Diploma and 7 to 9 years of experience in related fields
  • Understanding of GMP/GDP requirements.
  • Familiarity with raw material compendial testing
  • Experience overseeing quality of suppliers or external parties
  • Strong technical writing skills.
  • Strong experience in Alliance Management

Preferred Qualifications:

  • Strong continuous improvement attitude and lean practice's experience.
  • Understanding of end-to-end supply chain business processes.
  • Experience in project management across multiple departments and geographies.
  • Quick process understanding, insight and visualizing.
  • Strong analytical and problem-solving skills.
  • Independent self-starter, able to work autonomously, under pressure and in teams.
  • GMP/GDP knowledge and understanding of pharmaceutical regulations.
  • Energetic, detail oriented, highly motivated with a can do outlook.
  • Change management skills.
  • Ability to communicate across all levels of the organization.
  • Effective written and verbal communication skills.
  • Experience with Microsoft Office Tools including Excel, Word, and PowerPoint.
  • Ability to multi-task and prioritize

Employment Type: Full Time, Permanent

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Flexible timing
Monday to Friday
International travel
Day Shift
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Amgen Benefits

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Health Insurance
Child care
Education Assistance
Employee volunteer program and company matching donation program
Flexible work environment
Competitive base pay and annual bonus opportunities
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Health Insurance
International Relocation
Child care
Gymnasium
Cafeteria
Work From Home +6 more
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