Quality control plays a crucial role in ensuring the quality of finished products and raw materials. We are seeking a Quality Control Specialist to carry out analytical testing with minimal OOS issues.
Responsibilities:
* Learn and understand various analytical methods, including HPLC, IR, UV, dissolution, and physical testing.
* Follow all relevant SOPs and adhere to pharmacopoeia standards, specifications, regulations, and industry guidelines.
* Perform timely analysis of raw materials, finished products, and contract manufactured products.
* 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 customer service level.
* 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 tasks, maintain good housekeeping, and uphold safety standards.
Key behaviors include 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 Quality Control Specialist. Strong MS Office skills. 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 issue escalation. Methodical, organized, and proactive approach. Willingness to learn and develop technical skills.