Quality Assurance Specialist
We are seeking a Quality Assurance Specialist to provide quality oversight and direction for the introduction of new products and materials at our client's site in Carlow. This is a hybrid role that will involve managing external parties, coordinating with cross-functional teams, and ensuring compliance with regulatory requirements.
Key Responsibilities:
* Provide quality oversight and direction for the introduction of new products and materials.
* Manage external parties and coordinate with cross-functional teams.
* 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 and material introduction.
* Develop and monitor supplier performance metrics.
* 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.
* Facilitate compliance direction for the site by adhering to divisional policies, guidelines, and regulatory requirements.
Requirements:
* A minimum of 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) is preferred.
* Strong report, standards, and policy writing skills.
* Experience with equipment and process validation.
* Familiarity with sterile filling processes and equipment.
* Proficiency in Microsoft Office and job-related computer applications.
* Experience or familiarity with Lean Six Sigma methodology is desired.
* Good collaboration skills and the ability to work effectively as part of a team to determine priorities.
* Demonstrated ability to work independently and take ownership of improvement initiatives with a moderate level of guidance.
* Proven ability to drive the completion of tasks.
* Strong decision-making capability with a sense of accountability and responsibility.
* Demonstrated problem-solving skills.
* A Bachelor's degree or higher in a related Science discipline is preferred.
Salary:
€50,000 - €65,000 per annum, depending on experience.
Location:
Carlow, Ireland.
Type:
Contract (11 months).