Purpose:

Performs and reviews all routine and non-routine testing and project work to ensure processes and end products comply with corporate and regulatory requirements to facilitate product release. Ensure that objectives are effectively achieved, consistent with the company’s requirements to ensure compliance, safety and reliable supply to our customers.

Responsibilities:

• Work as directed by the Quality Control Manager / Associate Director, according to Company safety policies, cGMP and cGLP. Required to drive compliance with company Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
• Required to comply with company Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
• Develop, implement and maintain procedures that comply with appropriate regulatory requirements.
• Ensure that all Quality Systems within the department are adhered to on a daily basis.
• Operate as part of the QC team performing the allocated testing and laboratory based duties.
• Participate in method transfers and provide technical expertise and troubleshooting to support analysis.
• Ensure timely completion of all assigned data processing and reviewing.
• Ensure timely completion of Laboratory Investigation Reports and deviations through site procedures.
• Participate in the timely generation of trend data, investigations, nonconformances, validation protocols, reports in support of method validation/verifications and equipment qualifications.
• Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc.
• Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved.
• Where applicable, review, approve and trend test results.
• Participate in the laboratory aspects of OOS investigations.
• Provide support with audit/inspection requirements to ensure department compliance/readiness.
• Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
• Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.
• Work collaboratively to drive a safe and compliant culture in Carlow.
• May be required to perform other duties as assigned.

Minimum Qualifications and Experience:

• Bachelor’s Degree or higher preferred; ideally in a science related discipline.
• Knowledge of regulatory/ code requirements to Irish, European and International Codes, Standards and Practices.
• Knowledge of cGMP.
• Laboratory Quality Systems.
• Proficiency in Microsoft Office and job-related computer applications required.
• Report, standards, policy writing skills required.
• Understanding of Lean Six Sigma Methodology preferred.
• Understand the specific responsibilities of all Carlow departments as they relate to one’s own department, understanding the business processes one’s department supports
• Effective communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
• Data analysis.
• Training skills.