We are seeking a Quality Control Analyst to carry out analytical testing on finished products and raw materials, ensuring compliance with GMP, Health and Safety, SOPs, environmental, and regulatory requirements. The role involves providing technical support as required by management.
This position reports to the Quality Control Manager.
Location: Onsite in our Loughrea laboratory (5 days per week).
Responsibilities:
* Learn and understand analytical methods, demonstrating competency in HPLC, IR, UV, dissolution, and physical testing.
* Follow all relevant SOPs and adhere to pharmacopoeia standards, specifications, regulations, and industry standards.
* Perform timely analysis of raw materials, finished products, and contract manufactured products with minimal OOS issues.
* Conduct incoming inspections of foils, labels, bulk finished goods, and injectables.
* Calibrate and maintain laboratory equipment as per procedures.
* Support testing schedules to achieve an efficient QC system and a customer service level >95%.
* Maintain laboratory documentation to GLP standards.
* Coordinate with team leaders and production for timely reporting and feedback.
* Report discrepancies, deviations, or non-conformances and follow up on corrective actions.
* Send samples for external analysis when needed.
* Participate in audits and liaise with external suppliers/vendors.
* Ensure adherence to quality procedures and suggest improvements.
* Perform assigned internal rota tasks, maintain good housekeeping, and uphold safety standards.
* Keep QC records updated and properly filed.
* Demonstrate key behaviors such as teamwork, initiative, systematic work approach, prioritization, and flexibility.
Education & Experience:
* Bachelor’s degree in a chemistry-based discipline.
* 2–5 years of experience as a QC Analyst.
* Strong MS Office skills.
* Experience in a pharmaceutical cGLP environment with knowledge of EU, GMP, and US FDA guidelines.
* Eligible to work in Ireland.
Skills & Competencies:
* Technical proficiency in HPLC, IR, UV, dissolution, and physical testing.
* Strong communication and relationship-building skills.
* High ethical standards and appropriate issue escalation.
* Methodical, organized, and proactive approach.
* Willingness to learn and develop technical skills.
We encourage applicants from diverse backgrounds, including those returning after a career break or with transferable skills from non-traditional paths. We are committed to fostering an inclusive environment that supports individuals with disabilities.
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