MSD Quality Specialist - Systems Compliance 

Ireland 

220497491

Job Description

Theat our Carlow Site will ensure compliance of vaccine and biologics manufacturing processes with cGMP and regulatory requirements. This role involves providing cross-functional support, facilitating compliance, and supporting quality systems, monitoring, and management. Ideal candidates will have 3-5 years of pharmaceutical/regulatory experience and a strong working knowledge of aseptic processing and environmental monitoring in a sterile manufacturing facility. The role also includes liaising with technical experts from other sites and providing technical expertise and training in various operational areas.

What you will do:

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

• Ensure compliance with cGMP and regulatory requirements for vaccine and biologics manufacturing processes
• Act as site lead for nominated quality systems and support their continuous improvement
• Participate in Plant/Quality committees and collaborate with other site functional groups
• Provide support and advice cross-functionally on day-to-day and project basis
• Develop and implement improved quality reporting measures
• Liaise with technical subject matter experts from other company sites
• Initiate and maintain quality-related metrics and drive change in quality systems

What skills you will need:

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

• 3-5 years of experience in pharmaceutical/regulatory environment
• Bachelor's degree in a related Science discipline
• Strong working knowledge of aseptic processing and sterile manufacturing
• Proficiency in EU/US quality-related pharmaceutical regulations
• Knowledge of regulatory/code requirements and industry best practices for quality and compliance
• Experience with Lean Six Sigma Methodology preferred
• Strong verbal and written communication skills, project management skills
• Proficiency in Microsoft Office and job-related computer applications
• Decision-making capability, problem-solving skills, and collaboration skills

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Posting End Date:09/24/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.