MSD Quality Assurance Specialist 

Ireland 

751006444

Job Description

Candidates must have, as this is crucial to the role's responsibilities. Additionally,is essential. The position requires 3-5 years of experience in a quality role, ideally within a pharmaceutical manufacturing environment. This opportunity allows the successful candidate to contribute significantly to the development and manufacture of vaccines and biological products, ensuring high-quality standards within the Carlow facility.

What you will do:

Bring energy, knowledge, innovation, and leadership to carry out the following:

• Provide quality oversight and direction for the introduction of new products and validation activities.
• Serve as the point of contact for quality at both the site level and with external inputs, coordinating and attending Quality working group meetings.
• Participate as a functional expert in the cross-functional team responsible for introducing products at Carlow.
• Conduct quality reviews and approvals ofengineering/validation/automation/utilitiescommissioning and qualification activities.
• 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 Investigations and 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. Actively participate in Plant/Quality committees and collaborate with other site functional groups.

What skills you will need:

In order to excel in this role, you will more than likely have:

• A Bachelor's degree or higher in a related Science discipline is preferred.
• 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 Continuous Improvement Mindset.
• 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.

please apply today.

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