Job Title:
QC Instrumentation Analyst (12-Months)
Location: Swords, Co. Dublin
About Us:
SK pharmteco is a global Contract Development and Manufacturing Organization (CDMO) with state-of-the-art facilities in Korea, the US, France, and Ireland.
We are part of SK Inc., a Korean company with revenues of $99 billion in .
Our mission is to produce and deliver life-changing therapies that improve patient outcomes and save lives.
The SK pharmteco Small Molecule Europe facility, located in Swords, Co. Dublin, has been at the forefront of the development, scale-up, and commercial manufacture of Active Pharmaceutical Ingredients (APIs) and Chemical Intermediates for over 60 years.
With a talented workforce, exceptional technical capabilities, and world-class facilities, we have manufactured some of the world's most important medicines — and continue to do so.
Learn more at .
Key Responsibilities
1. Manage and coordinate the laboratory instrumentation calibration and qualification programme with internal teams and external vendors (e.g., Agilent).
2. Prepare, review, and approve validation protocols and reports (IQ/OQ/PQ) for QC instruments and systems.
3. Manage change-control activities for instrument installations, relocations, decommissioning, and new purchases.
4. Oversee GMP documentation, ensuring traceability, data integrity, and audit readiness.
5. Review and close unplanned maintenance and deviation reports, implementing effective CAPAs.
6. Lead or support system-validation and requalification activities in alignment with GAMP 5 and regulatory guidelines.
7. Troubleshoot laboratory instrument and software issues and coordinate with vendors for resolution.
8. Develop, update, and maintain SOPs and technical documentation for laboratory equipment.
9. Support internal and external regulatory audits as the SME for QC instrumentation and validation.
10. Ensure all QC laboratory activities adhere to GMP, GDP, and data-integrity (ALCOA+) principles.
Minimum Requirements:
11. A BSc in Analytical Science, Chemistry, or a related discipline is required.
12. A minimum of 3 years of experience working in the pharmaceutical industry is required.
13. Knowledge of Quality Control operations and understanding of GMP in a regulated environment.
14. Experience preparing for and participating in Regulatory and Customer audits (FDA, HPRA, etc.).
15. Experience in Equipment Validation and Change Control procedures is desirable.
16. Strong ability to manage multiple tasks or projects, prioritize work, and meet timelines for equipment calibration, maintenance, and testing.
17. Proven ability to collaborate cross-functionally with QAS, IM, and multiple vendors.
18. Highly motivated, strong teamwork and problem-solving skills, with a record of success in a collaborative laboratory environment.