QC Instrumentation Associate Specialist

PSC Biotech Corporation; Carlow; On-site; EUR 70,000 - 95,000; Full time

Job summary

PSC Biotech Corporation in Carlow, Ireland, is seeking a senior Lab Systems & Instrumentation professional to ensure cGMP compliance and quality across the Lab.

You will oversee calibration activities, drive process improvements, and coordinate with external vendors while supporting audits and investigations. The role requires a degree in chemistry or science and 4–5 years of relevant experience.

Qualifications

• Bachelor's degree or higher in Chemistry, Science or a related discipline.
• Significant experience in GMP manufacturing or lab environments.
• Knowledge of cGMP and GDP preferred.
• Familiarity with data integrity requirements.
• Proficiency in Microsoft Office and related applications.

Responsibilities

• Drive compliance with cGMP and cGLP in daily activities and testing.
• Provide oversight for external vendor calibration and PM/OQ activities.
• Lead day-to-day oversight of external vendors and coordination.
• Facilitate communication across Lab Systems and Instrumentation teams.
• Collaborate with vendors and service suppliers to schedule activities.
• Review instrumentation lifecycle documents and qualification tests.
• Support audits and inspections for department readiness.
• Drive continuous improvement and root-cause analysis of system issues.

Skills

GMP knowledge

Quality systems

Vendor coordination

Documentation

Education

Bachelor's degree or higher in Chemistry/Science

Tools

Microsoft Office

Job description

• Industry Pharma/Biotech/Clinical Research
• Work Experience 4-5 years
• City Carlow
• State/Province Carlow
• Country Ireland

Job Description

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient’s expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.

Responsibilities:

• Work as directed by Lab systems & Instrumentationmanager according to Company safety policies, cGMP and cGLP. Required to drivecompliance with Global policies, procedures and guidelines and regulatoryrequirements and execute Good Manufacturing Practices (cGMP) in the performanceof day to day activities and all applicable job functions.
  
• Technical oversight and review for external vendorcalibration PM/OQ activities on Laboratory Instruments.
  
• Leadership activities including day to day oversight forexternal vendors.
  
• Facilitate and drive effective communication to ensuresuccess. Attend tier meeting for Lab systems and instrumentation function andother support functions as necessary ensuring that the relevant grouprepresentatives attend to confirm all testing and validation activities are onschedule.
  
• Liaise effectively with instrumentation/ equipmentvendors, service suppliers, and outsourced services etc.
  
• Author or peer review instrumentation lifecycle,commissioning and qualification testdocuments.
  
• Participates in any efficiency/ increased Lab capabilityprojects as detailed by Systems / Instrumentation Coach.
  
• Represent the QC Department on site/inter departmentalprojects.
  
• Provide support with audit/inspection requirements toensure department compliance/readiness. Participate in internal and externalaudits and inspections, taking the role of auditee for assigned areas ofresponsibility.
  
• Drive continuous improvement, perform root cause analysison system failures and substandard equipment performance, using standard toolsand 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 ofresources to implement suggestions/ideas of merit. On assignment, and dependingon experience, participate in or lead departmental initiatives on improvedcompliance and quality systemsGMP and cGLP. Required to drive compliance withMerck Global policies, procedures and guidelines and regulatory requirementsand execute Good Manufacturing Practices (cGMP) in the performance of day today activities and all applicable job functions.
  
• Work collaboratively to drive a safe and compliantculture
  
• May be required to perform other duties as assigned.
  

Requirements

Qualifications:

• Bachelors Degree or higher preferred; ideally inChemistry/Science or a closely related discipline
  
• Considerable experience and critical skills in the areaof expertise that add value to the business; ideally in similar role in aManufacturing/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 computerapplications required