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Opportunity as Quality Manager in Amgen

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Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Post: Quality Manager

Job Description
- 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 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)
- Liaise with internal and external partners to manage day to day operations associated with distribution and redressing process
- 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 including distributors on-boarding training
- Ensure Amgen personnel received adequate and continuous training to perform their task related to GMP and GDP activities including Amgen Quality Management System
- Actively participate on GMP intelligence to review local regulations in 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

Basic Qualifications
Minimum 10 years experiences in Quality Assurance function in the biotechnology/ pharmaceutical/ Medical device industry including experience in supplier, distributor & external laboratory auditing, due diligence and oversight.
4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Experience performing GMP, GDP and supply security oversight
Strong verbal and written communications skills. Must be able to effectively articulate ideas with all levels of an organization and across multiple cultures.
Self leadership and motivation with high personal integrity and application of Amgen Values & Leadership Behaviors in daily operations.
Proficient with computer software; including Word, Excel, PowerPoint, Network environment
Good understanding on GMP and GDP requirements (i.e. : PIC/s, EMEA, US FDA, ICH and CDSCO)
Fluent in English and Hindi
Must have excellent understanding on India Regulations including GMP, GDP, Licenses and Regulatory submission, must have experience in interact with local health authority and has good relationship with the authorities
Ability to travel Domestic up to 50 %

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Preferred Qualifications
Experience with Multi-National (MNC’s)
Experience with ISO 9001 and ISO 13485
Experience with Cold Chain management
Excellent in English Language
Capabilities in other Indian languages and dialects are an advantage
Worked overseas in US and Europe for a period of time

Additional Information:
Location: Mumbai, Maharashtra
Job ID: R-29274
Industry Type: Pharma/ Biotech/Clinical Research
End Date: 25th November, 2016

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