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QUALITY ENGINEER
Company:CPL |
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Job Reference Number |
14297919 |
Client ID: |
RI/JO098058 |
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Posted On: |
Mar 18 2010 |
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Location: |
GALWAY |
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Job Type: |
Permanent |
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Salary: |
NEGOTIABLE |
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Quality engineer for the west of Ireland;
Duties & Responsibilities
Reporting to the Quality Engineering Supervisor, the successful candidate will be responsible for the following activities:
• Co-ordination and implementation of Process Analytical Technology and Statistical Process Control
• Preparation and co-ordination of Process, Equipment and Software validation protocols and validation activities in conjunction with R&D and Engineering
• Provide quality engineering support to manufacturing, helping to ensure delivery of the highest production yields
• Understand and ensure compliance with the company's and external regulatory quality systems requirements
• Use and establish analysis techniques and other quality control tools to aid in decision making
• Identify opportunities for process and quality system improvements and work with task teams in Implementation
• Investigating root cause of quality issues and following through on corrective actions to prevent reoccurrence
Qualifications & Experience:
Will possess a Bachelor of Science Degree in Engineering / Technology particularly in Chemistry or Polymer Technology.
2 / 3 years experience in a Pharmaceutical Technology, Combination Product or related environment with direct experience in a QA environment (GMP regulated). Knowledge of regulatory requirements and guidelines, namely CFR Parts 210, 211 and 820, ICH and ISO13485 is necessary.
Experience of working with pharmaceutical chemistry data is an advantage. Excellent interpersonal and communication skills including report writing is necessary.
Experience in conducting Stability studies and knowledge of Cleaning Validation would be an advantage.
For more information please give me a call / email at Annemarie.fox@cpl.ie or 091 507507
