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: Manager QA
Job Description
• Coordinate and lead, or participate in, International Quality Supply Security audits of suppliers to Amgen and its subsidiary companies as well as contract facilities, including laboratories, manufacturers, service providers and quality systems.
• Apply an advanced knowledge of current regulations, standards and guidelines, in addition to expertise needed to assess Supply Chain Security.
• Review and assess new or revised India regulations, standards, and guidelines as related to product testing; provide sites with guidance on new regulatory compliance expectations and trends.
• Provide leadership toward resolving supplier GMP risks.
• Perform tasks and participate on project teams as assigned to assist in the timely completion of activities associated with the attainment of group, departmental, team and corporate goals.
• May provide support for regulatory inspections of facilities.
• Travel to Amgen and vendor locations within and outside of India.
Basic Qualifications
• Doctorate degree & 2 years of directly related experience
OR
• Master’s degree & 6 years of directly related experience
OR
• Bachelor’s degree & 8 years of directly related experience
OR
• Associate’s degree & 10 years of directly related experience
• Fluent written and spoken Hindi and English
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Preferred Qualifications
• Certified auditor to ISO or similar standard.
• MS degree and 8 years of related experience in a regulatory compliance position supporting the manufacture and testing of pharmaceutical products.
• Experience performing GMP audits of manufacturers of biologic and small molecule API and DP, and laboratories that perform testing for API and DP.
• Advanced knowledge of GMP regulations, compendia, guidance and industry practice as pertains to the manufacture and testing of biological and small molecule products.
• Demonstrated advanced ability to evaluate and apply regulatory requirements and guidelines to applicable situations.
• Excellent verbal and written communication skills, including technical writing.
• Strong ability to lead teams and effectively utilize team resources.
• Ability for overnight travel domestic and international about 35%.
• Speaking Gujarati and other Indian languages.
Additional Information:
Location: Mumbai
Auto req: 21816BR
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
End Date: 7th Feb, 2014
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