QC Documentation & Compliance Specialist

MSD Malaysia; Carlow; On-site; EUR 55,000 - 70,000; Full time

Job summary

MSD is hiring a Quality Control Associate Specialist at our Carlow site to support QC operations, investigations, and documentation in a cGMP environment. The role focuses on ensuring data integrity, regulatory compliance, and timely approvals of QC documentation.

Ideal candidates hold a Bachelor's or higher in Analytical Chemistry/Biochemistry with at least 4 years in cGMP QC, and hands-on experience with HPLC/ELISA systems and related software.

Qualifications

• Bachelor's degree or higher preferred in Analytical Chemistry/Biochemistry or related discipline.
• 4 years of cGMP Quality Control experience in pharma/biopharma.
• Experience with HPLC/ELISA systems and software.

Responsibilities

• Execute and support QC activities per Global Policies, Procedures and QMS.
• Ensure compliance with regulatory requirements and cGMP expectations.
• Maintain data integrity and inspection readiness.
• Review testing documentation and ensure data integrity and QC KPIs.
• Act as SME for QC documentation systems and lifecycle management.
• Mentor others in preparing compliant, high‑quality documentation.
• Support QC lab operations and GMP documentation for routine and atypical events.
• Support NPI, technology transfers and lifecycle activities from QC perspective.
• Assist deviation/investigation activities using root cause tools (FMEA, Fishbone, 5‑Why).
• Drive continuous improvement by identifying trends and gaps in QC processes.
• Stay updated on Irish/European/international regulatory expectations.

Skills

ELISA

GMP

HPLC

Regulatory compliance

Quality Control

QMS

Education

Bachelor's degree or higher in Analytical Chemistry/Biochemistry

Job description

MSD is hiring a Quality Control Associate Specialist at our Carlow site to support QC operations, investigations, and documentation in a cGMP environment. The role focuses on ensuring data integrity, regulatory compliance, and timely approvals of QC documentation.

Ideal candidates hold a Bachelor's or higher in Analytical Chemistry/Biochemistry with at least 4 years in cGMP QC, and hands-on experience with HPLC/ELISA systems and related software.