QA Operations Specialist

Job Description

An amazing opportunity has arisen for a QA Operations Specialist in our Biotech facility in Dublin.

This role provides direct Quality support to the Upstream production area as part of a Quality IPT (Integrated Product Team). With guidance from the Associate Director of Quality Operations the Quality Specialist ensures quality and compliance of products manufactured by the functional area adherence to Good Manufacturing and Documentation Practices and represents quality on the shop floor.

This is a shift role (4 x 12hr extended days followed by 4 days off).

What you will do:

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

• Responsible forreview/approvalof new and updated Master Batch Records/ Electronic Batch Records
• Review and approve production documentation such as executed electronic batch recordsandlogbooksto ensure accuracy and compliance withcGMPsand company procedures
• Provides presence on the shop floor to support complianceand data integrity
• Review and approve new and updated SOPs/ Work Instructions and Controlled Job Aides
• Actively participates in the Tier process and uses this forum to make issues visible and to partner with the functional area on resolution
• QA support review and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment.
• Will serve as the Quality SME for Performance qualification (PQ) activities across the site including but not limited to: Equipment Facility and Utility PQ studies Cleaning Validation SIP process validation
• Participates as the quality member on cross functional projects
• Support sustaining activities such as Change Management Deviations CAPAs Equipment Requalification and Periodic review Site Maintenance & Calibration Program
• Provides support to internal audits and regulatory inspections
• Collaborates with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans
• Drive continuous improvement and utilise problem solving tools. Participate in continuous improvement initiatives to enhance operational efficiency and resolve issues

What skills you will need:

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

Required

• Bachelors degree in a scientific or engineering field (preferred) or significant relevant experience in other fields.
• Minimum 5 years of relevant post-degree work experience in GMP Manufacturing Quality Assurance or Laboratory environment.
• Expertise with at least 2 years of working knowledge in the biotech industry specifically in QA operations.
• Strong interpersonal skills including flexibility collaboration and the ability to work in a team environment.

Preferred

• Experience with Quality systems pharmaceutical manufacturing or laboratory processes authoring and approving GMP documents
• Demonstrated analytical aptitude critical thinking skills and problem-solving skills
• Demonstrated leadership skills with strong oral and written communication abilities
• Bioprocessing knowledge upstream and or/ downstream

Within our Company in Ireland we work at the forefront of science and technology to advance manufacturing excellence and R&D across our Irish sites and global company network. Were always looking to make a difference for people patients and communities from our Company in Ireland to the world.

Ireland is one of the Irelands leading healthcare companies having first established here over 50 years ago. We have a dynamic team of over 3000 employees currently working across seven sites in Ballydine Co Tipperary Brinny Co Cork Dunboyne Co Meath Carlow Dundalk and Dublin where in addition operate substantial Human Health and Animal Health businesses. Through our long-standing footprint in Ireland and over $6 billion invested across our Irish operations our Irish sites manufacture many of our Companys top products helping save and enhance lives in over 140 countries around the world.

Our Biotech facility in Dublin began construction in 2018 and has progressed at an impressive rate since then. The site plays a pivotal role in the manufacture of our Companys biologics-based medicines including immuno-oncology and it has expanded our Companys current internal network of biologics drug substance manufacturing plants since full manufacturing operations began in 2021.

If you are ready to:

Invent solutions to meet unmet healthcare needs Impact the future by driving one of the worlds leading healthcare companies and inspire your team to reach their full potential and push the boundaries of science and technology please apply today.

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

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