Ireland-Cork: Quality Assurance Specialist

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 11-Feb-2008

Quality Assurance Specialist

Specific Responsibilities: Key responsibilities/activities of the position:

1. Performs a wide variety of activities to ensure compliance with applicable regulatory requirements. 2. Participates in developing Standard Operating Procedures to ensure quality. 3. Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs). 4. Reviews routine manufacturing, environmental monitoring and quality control data for in-process and finished products. 5. Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications. 6. May participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products. 7. May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products. 8. Works with Research and Development during new product start-ups, and identifies routine checkpoints for new products and processes. 9. May assist compliance audits as required. 10. May interface with contract manufacturers to address documentation and compliance issues. 11. Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed. 12. Works on assignments that range from routine to basic in nature where ability to recognize deviation from accepted practice is required. 13. Applies knowledge of current Good Manufacturing Practices (cGMPs) on a daily basis. Good verbal, written, and interpersonal communication skills are required. 14. Site/local Smartsolve Administrator: Performs account administration and maintenance for local site. Assigns roles and access privileges. Resolves local application questions and issues. Co-ordinates change control proposals with Global Administrator. Performs and/or co-ordinate changes with Global administrator. Runs audit trails as requested. Obtains User Requirements for changes. Co-ordinates user training for software changes and upgrades. Executes application-specific maintenance. Essential Duties and Job Functions: Maintains QA systems providing structures and processes for maintaining compliance and throughout the company's operations and business processes

Knowledge, Experience and Skills: Educated to diploma / degree level (sciences or business) or equivalent. Desirable (not essential) to have a higher degree, PhD or diploma in a business related topic

For more information, please write to us.

Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com