Quality Assurance Specialist

PSC Biotech Ltd; Munster; On-site; EUR 60,000 - 80,000; Full time

Job summary

PSC Biotech Corporation in Ireland seeks a contractor to support GMP Quality Assurance activities for the GDQ IMP Licence. You will perform data and document audits, ensure release conformance, and collaborate with cross-functional teams to maintain quality standards.

The role requires an Engineering or Science degree with substantial industrial GMP experience and a focus on quality processes across client sites in a global biotech environment.

Qualifications

• Degree in Engineering or Science discipline.
• 4–5 years industrial experience.
• GMP quality assurance exposure.

Responsibilities

• Completes audits of data, information, procedures, facilities, equipment and systems to ensure compliance to SOPs, GMPs and applicable regulations.
• Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to SOPs, GMP and regulatory requirements.
• Collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities; resolve comments during audit and review.
• Support product recalls and stock recoveries as appropriate.
• Identify compliance gaps and make recommendations for continuous improvement.
• Creates and maintains assigned SOPs.
• Perform and review complaints and deviation investigations, change controls and CAPAs.

Skills

Audit experience

GMP knowledge

Quality Assurance

Regulatory understanding

Education

Engineering or Science degree

Job description

Tipperary, Ireland | Posted on 11/02/2026

• Industry Pharma/Biotech/Clinical Research
• Work Experience 4-5 years
• 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

Role Description:

The Contractor is a member of a team within GlobalDevelopment Quality (GDQ) and is involved in supporting the GMP QualityAssurance activities for the GDQ IMP Licence at the site.

Requirements

Role Functions

• Completes audits of data, information, procedures,facilities, equipment and systems (inc computer systems) to ensure complianceto SOPs, GMPs and applicable regulations.
  
• Review and approve production and analyticaldocumentation accompanying the release of drug substance, drug product andpackaged finished goods to ensure conformance to appropriate SOPs, GMP andregulatory requirements, including supporting QP certification.
  
• Actively communicate and collaborate with functionalareas to develop a strong working relationship and understanding of roles andresponsibilities. Utilise this network to help resolve comments and issues thatarise during audit and review.
  
• Support product recalls and stock recoveries asappropriate.
  
• Identify compliance gaps and make recommendations forcontinuous improvement
  
• Creates and maintains assigned SOPs.
  
• Perform and review complaints and deviationinvestigations, change controls and CAPA’s.
  
• May assist in the induction process for new starters.
  
• Generally follows standard procedures and consults withmanager/supervisor on exceptions.
  
• Compiles data for reports and presentations - Mayinterpret data and draw conclusions.
  
• Carries out all assignments to the standards ofcompliance, efficiency, innovation, accuracy and safety in accordance withCompany and regulatory requirements.
  
• Keep abreast of cGMP requirements as described inapplicable worldwide regulations.
  
• Additional activities may be assigned by themanager/supervisor
  

Experience, Knowledge & Skills:

• The contractor is required to possess a degree in anEngineering or Science discipline.
  
• Alternatively, they must possess significant industrialexperience.
  

Qualifications & Education

• The contractor is required to possess a degree in anEngineering or Science discipline.
  
• Alternatively, they must possess significant industrialexperience.