Job Description: QC Instrumentation Analyst (12-month contract)
SK pharmteco, a global Contract Development and Manufacturing Organisation (CDMO), is seeking a QC Instrumentation Analyst for a 12-month contract. This role is based in the Instrumentation group within the QC Department at our facility in Swords, Co Dublin, Ireland.
Responsibilities include:
1. Coordinating calibration schedules with equipment suppliers like Agilent.
2. Reviewing laboratory calibration and qualification documentation.
3. Overseeing unplanned maintenance reports for laboratory equipment.
4. Managing changes, relocations, and decommissioning of laboratory instruments.
5. Troubleshooting laboratory equipment issues.
6. Managing procurement, installation, and qualification reports for new instruments.
7. Handling laboratory instrument change controls.
8. Developing and updating equipment procedures.
9. Conducting calibration investigations.
10. Supporting the qualification and routine maintenance of analytical instruments.
11. Ensuring GMP compliance in laboratory operations and documentation.
12. Managing relations with equipment suppliers for new equipment and software.
13. Fostering a culture of growth, enablement, and high performance.
Qualifications and Experience:
* BSc in Analytical Science, Chemistry, or a related discipline.
* Minimum of 3 years’ experience in the pharmaceutical industry.
* Knowledge of quality control operations and GMP regulations, including FDA standards.
* Experience with regulatory audits, equipment validation, and change control procedures is desirable.
* Strong workload management skills, ability to prioritize tasks, and meet deadlines.
* Excellent teamwork and communication skills, with the ability to interact with QAS, IM, and vendors.
The successful candidate will be highly motivated, proactive, and capable of working effectively in a team environment.
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