Senior Associate QA, International Distribution Quality
Amgen · Hyderabad · onsite · Posted 52d ago
Undisclosed3–7 yrsfulltimeSourced from
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About this role
Senior Associate QA, International Distribution Quality Job Summary
The Sr. Associate QA position will implement and oversee global product distribution and transportation from Amgens Global Supply Hubs to Amgens global markets and provide QA oversight of QA activities for Global Supply Chain operations. This role may require working in shifts or extended hours within the same shift.
Responsibilities - Perform QA Contact role on the Quality Events, Change Control records, Corrective and Preventive Actions, effectiveness verification and documentation, as well as QA triage of Distribution complaints.
- Work closely with all relevant collaborators for the end-to-end process and ensure compliance to GMP/GDP.
- Expertise in quality assessment associated with transport temperature excursion management.
- Expertise in assessing quality impacts of distribution deviations.
- Hands-on experience in internal audits or self-inspections.
- Demonstrated experience in batch disposition and release processes.
- Act as subject matter expert (SME) for transportation related Quality Processes.
- 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), Good Distribution Practices (GDP) and other applicable regulations.
- Collaborate with the 3rd Parties to ensure adherence to service levels, identifying and implementing performance improvement
- Understand and incorporate risk management strategy into overall supply chain strategy
- Provide support for logistic service provider and transportation service provider oversight
- Support in tactical activities for internal/external audits and inspections as part of the audit/inspection team
- Provide quality expertise and guidance to operational staff and within cross functional Amgen teams
- 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
- We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek is a strong leader with these qualifications:
- Bachelors degree in science or engineering and 2+ 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.
- Global Supply Quality Background.
- Distribution Quality background.
- Strong continuous improvement attitude 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.
- 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, Power BI and smart sheet.
- Ability to multi-task and prioritize
Sourced from naukri
Skills
CGMPBIOTECHmicrosoft officegeneral medicineauditsidqChange ControlChange ManagementBiotechnologyLogisticsoncologyperformance improvement planglobal supply chainCommunication SkillsManufacturingoperationscompliance
About Amgen
Amgen
Biotechnology
1.5k+
employees
1980
46 years old
Hyderabad, Telangana
India
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Amgen operates in the biotechnology sector, developing and delivering advanced medicines to address critical health challenges globally.
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