QC Instrumentation Associate Specialist

Role Summary:

• We are seeking an experienced QC Instrumentation Associate Specialist to join our client’s pharmaceutical site in Co. Carlow.
• The successful candidate will work as directed by Lab systems & Instrumentation manager according to Company safety policies, cGMP and cGLP. Required to drive compliance with the company’s 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.
• This is an Onsite role.

Core Duties and Responsibilities:

• Technical oversight and review for external vendor calibration PM/OQ activities on Laboratory Instruments.
• Leadership activities including day-to-day oversight for external vendors.
• Facilitate and drive effective communication to ensure success. Attend tier meeting for Lab systems and instrumentation function and other support functions as necessary ensuring that the relevant group representatives attend to confirm all testing and validation activities are on schedule.
• Liaise effectively with instrumentation/ equipment vendors, service suppliers, and outsourced services etc.
• Author or peer review instrumentation lifecycle, commissioning and qualification test  documents.
• Participates in any efficiency/ increased Lab capability projects as detailed by Systems / Instrumentation Coach.
• Represent the QC Department on site/inter departmental projects.
• 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.
• Provide input, review and approval for atypical, observation, and process capability investigations. Oversee coordination of resources to implement suggestions/ideas of merit. On assignment, and depending on experience, participate in or lead departmental initiatives on improved compliance and quality systems GMP and cGLP. Required to drive compliance with the company’s 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.
• Work collaboratively to drive a safe and compliant culture on site.
• May be required to perform other duties as assigned.

Minimum Qualifications and Experience:

• Bachelors Degree or higher preferred; ideally in Chemistry/Science or a closely related discipline
• Considerable experience and critical skills in the area of expertise that add value to the business; ideally in similar role in a Manufacturing/Laboratory environment, preferably in a GMP setting
• Knowledge of cGMP and GDP preferred
• Knowledge of data integrity requirements required.
• Proficiency in Microsoft Office and job-related computer applications required
• Lean Six Sigma Methodology experience desired

Please note, we do not require agency assistance with this role.