QC Instrumentation Analyst

2 weeks ago

Dublin, Ireland Cpl Healthcare Full time

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 2023.

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 www.skpharmteco.com.

Key Responsibilities

- Manage and coordinate the laboratory instrumentation calibration and qualification programme with internal teams and external vendors (e.g., Agilent).
- Prepare, review, and approve validation protocols and reports (IQ/OQ/PQ) for QC instruments and systems.
- Manage change-control activities for instrument installations, relocations, decommissioning, and new purchases.
- Oversee GMP documentation, ensuring traceability, data integrity, and audit readiness.
- Review and close unplanned maintenance and deviation reports, implementing effective CAPAs.
- Lead or support system-validation and requalification activities in alignment with GAMP 5 and regulatory guidelines.
- Troubleshoot laboratory instrument and software issues and coordinate with vendors for resolution.
- Develop, update, and maintain SOPs and technical documentation for laboratory equipment.
- Support internal and external regulatory audits as the SME for QC instrumentation and validation.
- Ensure all QC laboratory activities adhere to GMP, GDP, and data-integrity (ALCOA+) principles.

Minimum Requirements:

- A BSc in Analytical Science, Chemistry, or a related discipline is required.
- A minimum of 3 years of experience working in the pharmaceutical industry is required.
- Knowledge of Quality Control operations and understanding of GMP in a regulated environment.
- Experience preparing for and participating in Regulatory and Customer audits (FDA, HPRA, etc.).
- Experience in Equipment Validation and Change Control procedures is desirable.
- Strong ability to manage multiple tasks or projects, prioritize work, and meet timelines for equipment calibration, maintenance, and testing.
- Proven ability to collaborate cross-functionally with QAS, IM, and multiple vendors.
- Highly motivated, strong teamwork and problem-solving skills, with a record of success in a collaborative laboratory environment.

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