Quality Assurance Specialist Validation and NPI
An exciting opportunity has arisen for a Quality Assurance Specialist to join the quality team within a leading Biopharmaceutical Multinational.
Job Summary:
The successful candidate will play a vital role in supporting the introduction of new products and providing quality oversight for executed validation at our Carlow-based facility.
Key Responsibilities:
* Provide quality direction for the introduction of new products.
* Serve as the point of contact for quality, coordinating and attending Quality working group meetings.
* Participate as a functional expert in cross-functional teams responsible for introducing products.
* 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 products, such as QC Test Specifications, BOMs, and MES documentation.
* Support deviation close out in a timely manner.
* Facilitate compliance direction for the site by adhering to divisional policies, guidelines, and regulatory requirements.
* Proactively evaluate site compliance against emerging trends and initiate major compliance initiatives for improved status and operational efficiency.
Qualifications and Experience:
* 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.
* Experience in reviewing and approving documents associated with Equipment Validation, Cleaning validation, Sterilization, and other equipment.
* Knowledge of regulatory/code requirements related to Irish, European, and International Codes, Standards, and Practices.
* Familiarity with c GMP (current Good Manufacturing Practice) and GDP (Good Distribution Practice).
* Strong report, standards, and policy writing skills.
* Proficiency in Microsoft Office and job-related computer applications.
* Experience or familiarity with Lean Six Sigma methodology is desired.