Job Description
A fantastic opportunity has arisen for a Senior QA IT Specialist within our global Digital and Data Quality (DDQ) team. At our company, we are dedicated to ensuring the integrity and compliance of our manufacturing IT systems throughout the computerized system lifecycle.
Are you ready to make a significant impact on our cutting-edge manufacturing facility in Dundalk, Ireland? In this pivotal role, you will ensure high standards of IT system reliability, safety, and compliance within our state-of-the-art live virus drug substance and drug product manufacturing facility.
Your Key Responsibilities & Impact
You will collaborate with System, Process, Data, and IT Owners to select computerized systems that support GMP business processes.
Ensure selected technologies meet business needs, tailoring projects to fit complexity and risk.
Provide independent quality approval for critical qualification and validation documentation, ensuring high standards.
You'll maintain compliance with company standards and regulations throughout the computerized system lifecycle.
Verify that system owners uphold validated status with approved Operating Level Procedures/Plans.
Review processes and documentation to ensure compliance with computerized systems and data integrity.
Support regulatory inspections and audits, resolving nonconformance issues for GMP computerized systems and data integrity.
You'll monitor and communicate system health, compliance, and metrics updates to stakeholders, ensuring effective operation of manufacturing shopfloor systems.
What We’re Looking For
Required
You hold a Bachelor’s degree in a relevant field (e.g., Computer Science, Engineering, Life Sciences) or equivalent.
Hands-on experience with automated systems in pharmaceutical manufacturing, IT infrastructure, or laboratory operations.
Strong understanding of IT system change control, data integrity, and regulatory compliance.
You possess knowledge of computerized system validation and compliance principles.
Experience implementing quality systems in pharmaceutical, laboratory, or biotechnology environments.
Strong analytical problem-solving skills and the ability to integrate diverse perspectives.
Project management skills, with a sense of urgency and adaptability to changing priorities.
Preferred
It’s a bonus if you have experience in regulatory inspection and audit activities.
An advanced degree in a relevant field is likewise beneficial.
Certification in project management or quality assurance is a nice-to-have.
Required Skills:
Biopharmaceutical Operations, Change Management, Computer System Validation (CSV), Data Integrity, Deviation Management, GMP Compliance, Manufacturing Quality Control, Quality Assurance (QA), Quality Management Systems (QMS)Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
Secondary Language(s) Job Description:
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.
We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.
Please feel free to speak to us about what flexibility means to you during your application.
So, if you are ready to:
Invent solutions to meet unmet healthcare needs, please apply today.
Search Firm Representatives Please Read Carefully
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:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
12/10/2025*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.