Working independently, the individual will be responsible for, but not limited to the following:
- Perform QA Contact role on Quality Events, Change Control records, Corrective and Preventive Actions, effectiveness verification, and documentation.
- Work closely with all relevant stakeholders for the end-to-end process and ensure compliance with GMP/GDP.
- Prepare, review, and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, ensuring alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP), and other applicable regulations.
- Collaborate with raw material suppliers to ensure adherence to quality agreements, identifying 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.
- Work under minimal supervision in line with Amgen Values and Leadership Attributes.
- This role may require working in shifts or extended hours within the same shift to support global timezones.
What we expect of you
Basic Qualifications:
- Master's degree and 1 to 3 years of professional experience in related fields OR
- Bachelor's degree and 3 to 5 years of professional experience in related fields OR
- Diploma and 7 to 9 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.
- Strong technical writing skills.
Preferred Qualifications:
- Experience and strong familiarity with digital tools and computerized systems.
- Strong continuous improvement approach and lean practices 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 skills.
- 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.
