Job Title: QA Validation Specialist (New Product Introduction)
We are seeking a highly skilled QA Specialist to join our Technical Transfer and Validation team. The ideal candidate will have experience in quality assurance, validation, and new product introduction.
Key Responsibilities:
* Provide quality oversight and direction for the introduction of new products
* Coordinate and attend Quality working group meetings
* Conduct quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities
* Author, review, and approve protocols and reports for technology transfer, method qualification, and method validation
* Review documentation associated with new product, such as QC Test Specifications, BOMs, and MES documentation
* Support deviation close out in a timely manner
Requirements:
* Bachelor's degree or higher in a related Science discipline
* Minimum 3-5 years of experience in a quality role, ideally in a pharmaceutical manufacturing environment
* Knowledge of regulatory/code requirements related to Irish, European, and International Codes, Standards, and Practices
* Familiarity with cGMP (current Good Manufacturing Practice) and GDP (Good Distribution Practice)
* Strong report, standards, and policy writing skills
Desirable Skills:
* Experience with equipment and process validation
* Familiarity with sterile filling processes and equipment
* Experience or familiarity with Lean Six Sigma methodology