QC Instrumentation Specialist: Compliance & Optimization

PSC Biotech® Corporation; Carlow; On-site; EUR 60,000 - 90,000; Full time

Job summary

PSC Biotech is a leading Biotech Consultancy with global reach and a focus on quality management and regulatory inspections. We seek a highly capable professional to oversee lab systems, ensure cGMP compliance, and drive continuous improvement across QC operations.

You will lead external vendor oversight, coordinate calibration and qualification activities, and support internal audits. Strong knowledge of data integrity, GDP, and Lean Six Sigma is advantageous.

Qualifications

• Bachelor’s degree in Chemistry or related science.
• Experience in GMP manufacturing or laboratory setting.
• Knowledge of data integrity and GDP preferred.
• Proficiency with Microsoft Office and related software.
• Lean Six Sigma experience desirable.

Responsibilities

• Work as directed by Lab systems & Instrumentation manager according to Company safety policies, cGMP and cGLP.
• 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 systemsGMP and cGLP. Required to drive compliance with Merck 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.
• Work collaboratively to drive a safe and compliant culture
• May be required to perform other duties as assigned.

Skills

cGMP knowledge

GDP knowledge

Data integrity

Microsoft Office

Lean Six Sigma

Education

Bachelor's degree or higher in Chemistry/Science or related discipline

Job description

PSC Biotech is a leading Biotech Consultancy with global reach and a focus on quality management and regulatory inspections. We seek a highly capable professional to oversee lab systems, ensure cGMP compliance, and drive continuous improvement across QC operations.

You will lead external vendor oversight, coordinate calibration and qualification activities, and support internal audits. Strong knowledge of data integrity, GDP, and Lean Six Sigma is advantageous.