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Plant Quality Manager

ID:
1005508
Data:
17-09-2012
Empresa:
Technical Staffing Specialists, Inc.
País:
Estados Unidos
Localidade:
North Carolina
Categoria(s):
Informática e Tecnologias

Registada há 2 anos no SAPO Emprego 90614 ofertas anunciadas nos últimos 6 meses

Detalhe da Função

Will serve as a Plant Quality Manager for a growing organization. This candidate will need to make calls on the quality of product, including particulate issues, foreign matter, glass and molding defects, etc. Will manage 45+ people with a direct staff of 6

Requirements include:
• 10+ years of experience within the pharmaceutical industry
• At least 8 years experience in the manufacturing of (Parenteral) sterile injectable products. Medical Devices may be suitable as long as they are highly complex such as implantable devices
• Broad Quality Experience including:
§ QC experience in laboratory
§ QA experience - making active decisions in the quality world in manufacturing
§ QS - Quality Systems
§ Validation
§ Product release
• CAPA experience
• Recall experience, Field Alert Report, understanding of Regulatory compliance issues
• Expert knowledge of cGMP (Current - Good Manufacturing Practices) requirements
• Complete understanding and application of principles, concepts, practices, and standards for testing performed in all QC laboratories
Understanding of the Microbiology and Chemistry laboratories environment
• In process and finished product testing
• Sterility testing
• Concepts of bioburden
• Aseptic processing is desired
• Candidates we will be interested in must be extremely established as a positive leader capable of managing significant change.
• "Turn around" experience is helpful
• Experience working through a complete reorganization of the Quality group
• Experience in dealing with significant compliance challenges
• Significant change management
• Directly managing multiple Regulatory inspections
• Experience with FDA and European regulatory authorities
• Experience with Hosted / managed regulatory inspections
• 7 years in a managerial role managing a team(s) of Quality individuals (multi-shift operation)
• Bachelor of Science in Chemistry or Life Science/ MS preferred
(Biology, Biotechnology, or other scientific degree. An Engineering degree may suffice); Masters Degree is preferred

USE REFERENCE #091203
INCLUDE SALARY HISTORY AND REQUIREMENT

Employment Type: Any
Duration:
Work Hours: Full Time
Salary Currency: US Dollar . USD
Salary Period: Annual
Salary (Additional):

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