Basic Role Summary:
To carry out analytical testing on finished products, raw materials, and stability samples using approved procedures to ensure compliance with GMP, Health and Safety, SOPs, and environmental and regulatory requirements while meeting customer needs.
The role also provides technical support to the QC Laboratory as required by management.
Location:
Onsite at our QC Laboratory in Loughrea.
As our QC Analyst, your key responsibilities will be as follows:
Perform analytical testing of finished products, stability samples, and raw materials using appropriate techniques in a timely manner.
Demonstrate competence and develop technical capability in HPLC, GC, IR, UV, dissolution, and physical testing.
Maintain and follow all relevant SOPs, pharmacopoeial methods, specifications, and regulatory requirements.
Complete full analysis of products (tablets, granules, liquids, veterinary drenches, etc.) with minimal analyst-related OOS results.
Calibrate and maintain laboratory equipment in accordance with calibration schedules and procedures.
Support laboratory testing schedules to achieve an efficient QC system and customer service levels greater than 95%.
Maintain laboratory logbooks, notebooks, and associated documentation in line with GLP standards.
Liaise with supervisors, managers, and Production to ensure timely reporting of analytical results.
Provide timely feedback on analytical queries and support investigations where required.
Review and approve QC documentation as authorised.
Escalate discrepancies, deviations, or non-conformances to the QC Team Leader or Supervisor.
Support and follow up on corrective actions arising from testing or audits.
Send samples for external analysis when required and liaise with external suppliers and vendors for QC consumables.
Participate in internal and external audits.
Support continuous improvement by raising change controls where appropriate.
Adhere to internal laboratory rota tasks as agreed.
Maintain high standards of housekeeping, hygiene, and laboratory safety at all times.
Ensure QC records are accurate, complete, and properly filed.
Take direction, collaborate effectively with team members, and demonstrate flexibility and a willingness to support others.
Carry out any other duties assigned by the QC Team Leader, Supervisor, or Manager.
Qualifications and Experience:
Bachelor's degree in a science-based discipline.
2+ years' experience in a QC Analyst role.
Minimum of 2 years of relevant experience in a pharmaceutical cGLP environment with knowledge of EU GMP and US FDA guidelines.
Strong computer skills in Microsoft Office.
Skills and Competencies:
Competence in analytical techniques including HPLC, IR, UV, dissolution, and physical testing.
Strong attention to detail and compliance focus.
Good verbal and written communication skills.
Ability to work in a methodical, systematic, and structured manner.
High ethical standards with appropriate escalation of issues.
Flexible, proactive, and motivated to develop technical expertise.
Positive team contributor with strong collaboration skills.
Applicants from diverse backgrounds, including those returning after a career break or with transferable skills from non-traditional career paths, are encouraged to apply.
We value varied experiences and are committed to fostering an inclusive environment that supports individuals with disabilities.
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