Job Description
A fantastic opportunity has arisen for a DDQ Senior Specialist (QA IT) for Capital Projects. You will be part of the global Digital and Data Quality (DDQ) team and will ensure 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.
How You'll Make a Difference
* You'll collaborate with various system and process owners to select computerized systems supporting GMP business processes.
* Ensure selected technologies meet business needs and tailor projects appropriately for complexity and risk.
* Provide independent quality approval for key qualification and validation documentation.
* You'll ensure compliance with company standards and regulations throughout the computerized system lifecycle.
* Monitor that site and above-site system owners maintain validated status through approved procedures.
* You'll review processes and documentation to ensure effective compliance activities for computerized systems and data integrity.
* Support regulatory inspections and audits, resolving nonconformance issues for GMP computerized systems.
* You'll monitor and communicate system health and compliance metrics to stakeholders, ensuring effective operation of manufacturing systems.
Required
What You Bring to the Team
* You hold a Bachelor's degree in a relevant field or have equivalent experience.
* Hands-on experience with automated systems in pharmaceutical manufacturing, IT infrastructure, or laboratory operations.
* You have a strong understanding of IT system change control, data integrity, and regulatory compliance.
* Knowledge of computerized system validation and compliance principles.
* Adept at implementing quality systems in pharmaceutical, laboratory, or biotechnology environments.
* Strong analytical and problem-solving skills that enhance team goals.
* Ability to integrate diverse perspectives to bolster team success.
* Project management skills demonstrated by delivering quality results and adaptability to changing priorities.
Required Skills
Capital Projects, Change Management, Communication, Computer System Validation (CSV), Data Integrity, Deviation Management, Pharmaceutical Manufacturing, Pharmaceutical Quality Assurance, Project Management, Quality Assurance (QA), Quality Management Systems (QMS), Strategic Planning
Preferred Skills
Current Employees apply HERE
Current Contingent Workers apply HERE
Secondary Language(s) Job Description
We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.
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
Regular
Relocation
VISA Sponsorship
Travel Requirements
Flexible Work Arrangements
Hybrid
Shift
Valid Driving License
Hazardous Material(s)
Job Posting End Date
12/10/2025
* A job posting is effective until PM 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.
Requisition ID
R374989