Job Description
Key Responsibilities:
* 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.
* Develop and monitor supplier performance metrics, participate in material review boards and quarterly reviews of key suppliers.
* Maintain the approved supplier management list within the qualified Supplier Management system.
* Support deviation and atypical closeout, as well as initiate and follow up on corrective and preventive actions.
Requirements:
* Bachelor's degree or higher in a related Science discipline preferred.
* 3-5 years 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 and GDP preferred.
* Strong report, standards, and policy writing skills.
* Experience with equipment and process validation.
* Proficiency in Microsoft Office and job-related computer applications.
* Experience or familiarity with Lean Six Sigma methodology desired.
* Good collaboration skills and ability to work effectively as part of a team.
* Strong decision-making capability with a sense of accountability and responsibility.
* Demonstrated problem-solving skills.
Skills: Quality NPI GMP Equipment Validation