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PRINCIPAL STABILITY ENGINEER
Company:BOND PERSONNEL GROUP |
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Job Reference Number |
13317889 |
Client ID: |
RI/20756 |
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Posted On: |
May 21 2009 |
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Location: |
GALWAY |
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Job Type: |
Permanent |
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Salary: |
DEPENDENT ON EXPERIENCE |
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Provides focused Quality Assurance input to the Global Stability organization including participation in stability and shelf life programs, policies, processes, procedures and controls.
The objective of this role is to ensure that performance and quality of products conform to established internal and external standards and agency guidelines to provide lasting customer satisfaction.
The candidate will interface with multi-site, cross-functional groups to provide requirements and guidance for stability programs as well as collaborating with the Global Analytical organization.
Establishes and ensures compliance with relevant guidelines such as ICH, FDA guidance, ASTM etc. for testing and data analysis.
Works with Research and Development during new product start-ups, and establishes key checkpoints for new products and processes.
Provides stability direction for Regulatory strategy regarding new product submissions, including clinical/IDE submissions and product/process changes.
Provide stability reporting for required Regulatory submissions.
Duties and Responsibilities:
- Manages the activities of the team, managing resources, providing guidance and performance feedback to group members.
- Assists in and/or manages functional deliverables and ensures technical excellence in the development and management of stability programs.
- Provides guidance and approval regarding quality strategies for stability and shelf life as appropriate
- Assists in identifying and developing department tools and Quality Systems for the development of stability and shelf life strategy
- Maintains and enhances cross-functional team relationships.
- Works cross-functionally in identifying and resolving technical issues.
- Monitors and evaluates project and department progress and results.
Minimum Education & Experience:
- 10+ years experience in stability/shelf life within the pharmaceutical or device combination product area with a minimum of 2 plus years of supervisory experience preferred.
- Experience in supervising employees, providing feedback and guidance as to their performance and professional development.
- Experience with ICH and FDA guidance on Stability for combination products and/or pharmaceutical products strongly preferred.
- Good oral and written communication as well as interpersonal skills are required
- Product Development Project related experience is required
- Self starter with strong, proactive work ethic
- Ability to collaborate well with cross-functional colleagues especially in R&D, Operations and Regulatory
Postion will be based in Galway and will involve occasional domestic and international travel to other facilities
Salary dependent on experience
To take advantage of this opportunity call Tanya on (090)6493882 or send your cv
