Senior Associate QA, Distribution Quality
On-site · Hyderabad, Telangana, India
Job Summary
The Senior Associate QA role at Amgen focuses on implementing and overseeing global product distribution and transportation for quality assurance within the International Distribution Quality team. Responsibilities include serving as the QA contact for quality events, ensuring GMP/GDP compliance, reviewing and approving SOPs and documentation, and providing quality guidance across teams. Candidates should have a Bachelor’s or Master’s degree in science or engineering, relevant professional experience, and a strong familiarity with GMP/GDP requirements and logistics processes.
Required Qualifications
- Bachelor’s or Master’s degree in science or engineering
- 5-9 years of professional experience in related fields
- Understanding of GMP/GDP requirements
- Familiarity with logistics processes of parcel, transport, and warehousing providers
- Experience in Validation/Qualification of processes, equipment, and facilities
- Strong technical writing skills
Desired Qualifications
- Strong background in Global Supply and Distribution Quality
- Solid GMP/GDP knowledge
- Understanding of end-to-end pharmaceutical supply chain processes
- Strong continuous improvement and Lean mindset
- Excellent analytical and problem-solving skills
- Strong change management skills
Additional Requirements
- Staff must notify their current manager if invited for an interview
- Staff are ineligible to apply for open positions if their performance is currently being managed on a performance improvement plan (PIP) or other locally utilized formal coaching document
- Staff are ineligible to apply for open positions if their most recent performance rating was not a 'Partially Meets Expectations' or higher
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