India Quality Manager

Main Responsibilities

• Implement Amgen Quality Management System
• Identify Continuous Improvement opportunity for Quality Management System
• Develop Quality Procedures align with Amgen Quality Management System, cGMP requirements, GDP requirements and local regulations
• Oversight operations of local distributors and stockist to ensure local distributors operations are in compliance with cGMP requirements, GDP requirements, Amgen Quality Management System and Local regulations
• Act as Quality-related interface with internal and external customers (i.e. : Change control, Non Conformance, Product Complaint, Product Recall, Audit / Inspection)
• Support local testing
• Support BD project and product launches
• Liaise with internal and external partners to manage day to day operations associated with distribution operations
• Monitor and ensure on time completion of NC, CAPA, Audit observation, Product complaint and other quality events
• Develop and Maintain the Quality Agreements with local distributors and partners
• Develop reports and provide the necessary communications throughout the organizations
• Develop or review or approve GMP and GDP documents Provide training to distributors and stockiest including distributors / stockist on-boarding training
• Actively participate on GMP intelligence to review local regulations, standards and guidance related to Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), product testing and Pharmacopoeia requirementsin India.
• Collaborate with Risk Management and Product Security on handling of counterfeit, product tempering, product theft and product diversion
• Interact with local regulators as needed.
• Keep the Senior Manager International Quality JAPAC informed of the progress of projects and goals and advise on the potential areas of risk / concern and new developments that may impact the company
• Support Named Patient Program
• Supplier Management : Perform quality oversight and audit of key suppliers to Amgen and its subsidiary companies. These suppliers can include API and starting material manufacturers as well as raw materials, devices and finished products suppliers, contract facilities, local laboratories, importers, distributors, logistics service providers, warehouse, etc.
• Apply advanced knowledge of Indian and global market regulations to assess supply security risks.
• Work on an active risk management tool etc. to appropriately deploy Quality Systems on oversight of Amgen suppliers; including selection and approval, due diligence assessment, intelligence monitoring, on-site visit / audit and (if needed) Person in Plant placement, etc..
• Support in identifying, assessing and addressing suppliers GMP / GDP risks in collaboration with Amgen sites.
• Execute necessary tasks and projects as assigned by management in timely manner; to attain assigned goals.
• Provide support for regulatory inspections of key facilities as needed.

What we expect of you

Qualifications

Skills Required

Gdpr, Quality Management System, Supplier Management