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US-Missoula-Montana: QA FDA Regulatory Affairs
To see other opportunities,
please visit http://sqa.fyicenter.com
Date: 26-Mar-2009
QA FDA Regulatory Affairs
Description
Experienced QA FDA Regulatory Affairs person needed to join our talented, fast paced nutraceutical manufacturing team. Responsible for managing validation and stability processes, provide guidance and support to maintain change control system, and oversee CAPA system. Must be able to work in a high paced environment and maintain professionalism under pressure. Successful candidate must have previous Validation and Change Control experience and possess strong planning and organizational skills. Responsibilities Regulatory Assists in FDA inspections and third party audits. Researches current and developing regulations and improve internal systems accordingly. Provide regulatory advice and support to assigned products/teams Validation and Stability Study project management Oversee all aspects of the validation program. Manage Stability Study projects. Change Control Participate in the company’s change control review and approval system. Identify, develop and improve the change control system. Corrective Action / Preventative Action (CAPA) Review and approve investigations, CAPA plans, corrective actions, and deviations. Perform follow up effectiveness checks. Document Review and Data Analysis Establish data analysis on key metrics
Requirements
QUALIFICATIONS Minimum Skills and Abilities Required Good interpersonal skills, ability to provide constructive feedback and coaching. Strong oral and written communications inclusive of negotiation skills. Attention to detail and accuracy in work flow and organizational and analytical skills. Ability to manage time effectively and meet deadlines and requirements accordingly. Ability to perform in a fast pace environment with minimal direct supervision.
Minimum Education and /or Experience Required Four years college education preferred. Two (2) to four (4) years pharmaceutical Quality Control, Quality Assurance or manufacturing experience. Two (2) years pharmaceutical validation and change control experience. PC and software skills MAPICS Database Microsoft Suite
To apply for this position, please visit
this Website.
Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com
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