QC Instrumentation Specialist

Prochem Engineering; Leinster; On-site; EUR 60,000 - 85,000; Full time

Job summary

Prochem Engineering is seeking an experienced QC Instrumentation Associate Specialist for an onsite pharma site in Carlow. You will ensure cGMP compliance, oversee external vendors, and drive instrument lifecycle documentation and investigations.

The role emphasizes data integrity and quality systems within a GMP environment. The successful candidate will collaborate across Lab systems and instrumentation teams, support audits, and lead continuous improvement initiatives to enhance lab

Qualifications

• Bachelor's degree or higher in Chemistry/Science or related discipline.
• Valued GMP/lab experience in manufacturing or laboratory settings.
• Knowledge of data integrity requirements preferred.
• Proficiency with Microsoft Office and related software.
• Lean Six Sigma methodology experience desired.

Responsibilities

• Technical oversight and review for external vendor calibration PM/OQ activities on Laboratory Instruments.
• Leadership oversight for external vendors and day-to-day activities.
• Facilitate communication; attend tier meetings to track testing and validation schedules.
• Liaise with instrument vendors, service suppliers, and outsourced services.
• Author or peer-review instrumentation lifecycle, commissioning and qualification documents.
• Contribute to efficiency and capability projects per Systems/Instrumentation Coach guidance.
• Represent the QC Department on site and inter-department projects.
• Support audits/inspections to ensure compliance and readiness; participate as auditee as needed.
• Drive continuous improvement; perform root cause analyses using standard tools.
• Provide input for investigations; coordinate resources for improvements in GMP/cGLP processes.
• Promote a safe, compliant culture on site; may perform additional duties as assigned.

Skills

Data integrity knowledge

cGMP knowledge

Microsoft Office proficiency

Lean Six Sigma experience

Education

Bachelor's degree in Chemistry/Science or related discipline

Job description

Role Purpose

• 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.

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