Sr Associate Quality Assurance Specialist

2 days ago

Hyderabad Secunderabad Telangana, India beBeeQuality Full time

Job Title: Sr Associate Supplier Quality

Job Description:

The Sr Associate Supplier Quality position is accountable for overseeing the quality and compliance of raw material suppliers. This role plays a crucial part in ensuring that our company maintains high standards of quality and adheres to relevant regulations.

This position involves collaborating with various stakeholders, including business operations, analytical science, process development, and supply chain teams. As an integral quality member of the Amgen multi-functional raw materials suppliers' team, you will be responsible for the following key tasks:

  • Perform QA Contact role on quality events, change control records, corrective and preventive actions, effectiveness verification, and documentation.
  • Work closely with all relevant stakeholders to ensure end-to-end process compliance with GMP/GDP regulations.
  • Prepare, review, and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements.
  • Collaborate with raw material suppliers to ensure alignment with quality agreements and identify performance improvement opportunities.
  • Understand and incorporate risk management strategy into the overall raw material lifecycle.
  • Provide support to supplier periodic monitoring oversight activities.
  • Support tactical activities related to internal/external audits and inspections.
  • Perform routine quality assessments and provide approval of changes to raw material inspection profiles.
  • Take part in operational improvement initiatives, programs, and projects.
  • Develop solutions that are thorough, practical, and consistent with functional objectives.
  • Ownership of supplier metrics, performance assessments, and other key documents to inform the health of supplier relationships.
Required Skills and Qualifications:

To excel in this role, you should possess the following skills and qualifications:

  • Bachelor's degree in science or engineering and 2+ years of professional experience in related fields.
  • Understanding of GMP/GDP requirements.
  • Familiarity with raw material compendial testing.
  • Experience overseeing the quality of suppliers or external parties.
  • Deep technical writing skills.
What We Expect of You:

We seek a strong leader with excellent communication and problem-solving skills. You should be able to work independently, under minimal supervision, and be a self-starter who can adapt quickly to new situations.

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