QC Instrumentation Associate Specialist

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

Who are we?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

About PSC Biotech

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

Take your Career to a new Level

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the "heartbeat" of PSC Biotech, we provide unparalleled empowering career development through Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client's expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Responsibilities

• Work as directed by Lab systems & Instrumentation manager according to Company safety policies, cGMP and cGLP. Required to drive compliance with 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.
• 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.

Requirements

Qualifications

Minimum Education

• Bachelors Degree or higher preferred; ideally in Chemistry/Science or a closely related discipline

Minimum Experience

• 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