A Validation Engineer is required by CareerWise Recruitment for our Co Cork based med device client.
Role of this position
- Own and support validation activities in a Medical Device regulated environment.
- Responsible for all Process Validation Executions.
- Responsible for all Software Validation Executions.
- Resolution of Problems encountered during validation.
- Ensure Consistency in validation/qualification approach across systems and projects.
- Provide guidance and direction in the preparation and execution of validation activities.
- Be fully conversant and up to date with GMP requirements for site-wide regulatory body compliance.
- Maintain Validation system including conducting Periodic Reviews.
- Participate in change control processes for manufacturing process and facility modifications.
- QQI Level 7 Degree Preferably in a Science, Electronics, Mechanical or Industrial Engineering.
- Minimum of 2 years Quality Assurance / Regulatory affairs experience.
- Experience in completing Process Validation's as per CDRH Guidance
- Experience in using Gamp 4 or Gamp 5 Software V and V Techniques .
- Ability to respond to common inquiries or complaints from internal customers and regulatory agencies.
- Ability to write standard operating procedures, training documents, and regulatory responses.
- Experience in statistical Analysis / DOE and DMAIC methods.
Please call Diarmuid Buckley today for further information on 021- 2355432/ 086 072775 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)