QA Specialist

PSC Biotech Ltd; Dunboyne; On-site; EUR 55,000 - 75,000; Full time

Job summary

PSC Biotech Corporation in Dunboyne, Ireland, seeks a QA Operations Specialist for an 11-month contract. The role supports clinical and commercial operations, batch review, and regulatory compliance in a multi-product facility. You will collaborate across site teams to uphold quality and process improvements.

Requirements include a science/pharmacy degree and at least 3 years in biotech/pharma, with experience in batch record review, deviations, and cGMP. Remote/hybrid options not specified.

Qualifications

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.
• Minimum 3 years’ experience in the biotechnology and/or pharmaceutical industry.
• Previous Experience in Batch Record Review and Manufacturing Operations is preferable.
• Previous Experience with deviation management/Change controls is preferable.
• Knowledge of cGMP regulations both domestic and international.
• Proven decision-making capability with full accountability and responsibility.
• Ability to think logically and be proactive under pressure.
• Ability to work as part of a team and on own initiative in a constructive manner.
• Possess strong problem solving and troubleshooting skills.

Responsibilities

• Provide QA oversight to the clinical and commercial operations at the facility including quality control, supply chain, engineering and manufacturing and support process technical transfers, analytical technical transfers, drug substance disposition and regulatory approvals.
• Responsible for supporting execution of an effective Quality system and accountable for quality oversight of quality management systems (CAPAs, Change Controls, Deviations Batch Documentation Review).
• Liaises with internal partners in support of daily operations.
• Coordinate with peer Quality groups to ensure on-time disposition of commercial Drug Substance.
• Ensures clear communication on issues and timely escalation as applicable.
• Helps maintain site practices and procedures related to clinical and commercial operations.
• Responsibility for adhering to domestic and international GMP regulations, cGMP’s, company policies, leadership behaviors, and performance and budget management.
• Champion site metrics to ensure targets are achieved, met and counter measures in place when applicable.
• Representing Quality on multidisciplinary teams.
• Executing company policies.
• Ensures new/revised quality system requirements are deployed to the Site.
• Ability to work on his/her own initiative in addition to working as part of a team.
• Possess strong problem solving and trouble shooting skills.

Skills

Biotech/pharma experience

Batch record review

Change control

cGMP knowledge

Problem solving

Teamwork

Working under pressure

Education

Science or Pharmacy degree

Job description

Dunboyne, Ireland | Posted on 11/10/2026

• Industry Pharma/Biotech/Clinical Research
• Work Experience 4-5 years
• City Dunboyne
• State/Province Meath
• 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 unit

Job Purpose:

• An amazing opportunity has arisen for a QA OperationsSpecialist. This role will be responsible for supporting the clinical andcommercials operational activities and batch record review and release, at the singleuse multi-product biotech facility. You will work across site teams to resolveissues and drive quality, EHS, learning, and continuous improvement, whileensuring compliance with cGMP and corporate regulations.
  
• 11 Month of Contract
  

Requirements

What you will do:

• Provide QA oversight to the clinical and commercialoperations at the facility including quality control, supply chain, engineeringand manufacturing and support process technical transfers, analytical technicaltransfers, drug substance disposition and regulatory approvals.
  
• Responsible for supporting execution of an effectiveQuality system and accountable for quality oversight of quality managementsystems (CAPAs, Change Controls, Deviations Batch Documentation Review).
  
• Liaises with internal partners (e.g. ManufacturingOperations, MS&T, Engineering functions etc) in support of dailyoperations.
  
• Coordinate with peer Quality groups to ensure on-timedisposition of commercial Drug Substance.
  
• Ensures clear communication on issues and timelyescalation as applicable.
  
• Helps maintain site practices and procedures related toclinical and commercial operations.
  
• Responsibility for adhering to domestic and internationalGMP regulations, cGMP’s, company policies, leadership behaviors, andperformance and budget management.
  
• Champion site metrics to ensure targets are achieved, metand counter measures in place when applicable.
  
• Representing Quality on multidisciplinary teams.
  
• Executing company policies.
  
• Ensures new/revised quality system requirements aredeployed to the Site.
  
• Ability to work on his/her own initiative in addition toworking as part of a team
  
• Possess strong problem solving and trouble shootingskills
  

What skills you will need:

• Degree or post-graduate qualification in Science,Pharmacy or equivalent.
  
• Minimum 3 years’ experience in the biotechnology and/orpharmaceutical industry.
  
• Previous Experience in Batch Record Review andManufacturing Operations is preferable
  
• Previous Experience with deviation management/Changecontrols is preferable
  
• Knowledge of cGMP regulations both domestic andinternational.
  
• Proven decision-making capability with fullaccountability and responsibility.
  
• Ability to think logically and be proactive underpressure.
  
• Ability to work as part of a team and on own initiativein a constructive manner.