QA Documentation Controller

Job Description

A fantastic opportunity has arisen for a QA Documentation Controller within the Quality Assurance team at our company Dundalk.

The QA Document Controller will support compliance to the Documentation Management System and compliance reporting on local QMS implementation.

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

• Operate and manage the Documentation Management System/s.
• Manage the Documentation Archiving System, including archiving and reconciliation of documentation.
• Issue and reconcile Controlled Documents, such as logbooks.
• Manage our company QMS local assessments and report implementation.
• Generate and provide compliance metrics.
• Deliver training and provide support on Documentation Management System/s.
• Perform QA review of SOPs, risk assessments, change controls, and other documentation associated with DS/DP manufacturing operations.
• Provide support to internal audits and regulatory inspections.
• Collaborate with cross-functional team members to identify and implement continuous improvement initiatives and action plans.
• Drive continuous improvement and participate in initiatives to enhance operational efficiency and resolve issues.
• Act as a role model for the QA function and the wider organization in adherence to our company corporate core values.

What skills you will need:

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

• BSc in Science or related discipline, or equivalent qualification with demonstrated experience.
• Demonstrated experience in the pharmaceutical industry within a Quality role, or within other highly regulated environments.
• Strong knowledge of cGxP requirements and regulations.

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.

Required Skills:

Accountability, Accountability, Aseptic Manufacturing, Audits Compliance, Communication, Corrective and Preventive Action (CAPA), Detail-Oriented, Digital Archiving, Documentation Review, Documentation Systems, Document Control Systems, Driving Continuous Improvement, GMP Compliance, Human Resource Management, Internal Inspection, Operational Efficiency, Pharmaceutical Management, Quality Assurance (QA), Quality Assurance Processes, Quality Assurance Tools, Quality Auditing, Quality Management, Quality Management Systems (QMS), Quality Standards, Regulatory Inspections {+ 3 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

01/21/2026

*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.