QA Operations specialist-Shift

PSC Biotech Corporation; Dunboyne; On-site; EUR 65,000 - 90,000; Full time

Job summary

PSC Biotech Corporation in Ireland seeks a QA Operations Specialist for a 11-month maternity cover contract. The role focuses on QA oversight, documentation, CAPA investigations and regulatory readiness at a state-of-the-art biotech facility. You will collaborate across Manufacturing, PD-TS and Engineering to uphold quality and compliance.

Required: degree in Science/Pharmacy and 4+ years QA experience, strong GMP knowledge, and excellent communication. Multinational environment exposure a plus.

Qualifications

• Bachelor's degree in Science or Pharmacy or equivalent.
• 4+ years of QA experience.
• Strong knowledge of quality management systems and GMP.
• Experience with internal audits and regulatory interactions.
• Excellent written and verbal communication.

Responsibilities

• Reviews and approves batch records, discrepancy reporting, investigations and CAPAs.
• Supports QA oversight of quality management systems and regulatory compliance.
• Coordinates with cross-functional teams to ensure on-time disposition of Drug Substance.
• Provides QA support for regulatory submissions and inspection readiness.
• Maintains site quality practices, procedures and documentation.
• Drives continuous quality improvement using tools like DMAIC/Lean QA.

Skills

QA operations

cGMP knowledge

CAPA & investigations

Regulatory inspections

Quality systems

Education

Bachelor's degree in Science/Pharmacy

Job description

Dunboyne, Ireland | Posted on 11/09/2026

• 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

• This role will be part of our QA Operations Self DirectedWork Team (SDWT) in our state of the art single use multi-product biotechfacility
  
• The QA Operations Specialist role involves supporting theoperational activities, technical transfers, regulatory approvals andcommercial operations at the single use multi-product biotech facility.
  
• The QA Operations Specialist will work across the siteself-directed work teams and hub teams to identify and resolve issues in orderto allow the site to deliver on our commit culture that support Quality, EHS,Learning and Continuous improvement.
  
• The QA Operations Specialist will be responsible forsupporting the Operations team, ensuring compliance with cGMP and corporateregulations.
  
• 11 months of maternity cover

Requirements

Key accountabilities:

• Reviews and approves batch records, discrepancyreporting, investigations and CAPAs associated with all areas of Manufacturingoperations.
  
• Liaises with internal partners (e.g. ManufacturingOperations, Process development Technical services (PD-TS), Engineeringfunctions etc) in support of daily operations.
  
• Responsible for supporting execution of an effectiveQuality system and accountable for quality oversight of quality managementsystems (CAPAs, Change Controls, Deviations Batch Documentation Review).
  
• Coordinate with peer Quality groups to ensure on-timedisposition of commercial Drug Substance.
  
• Ensures clear communication on issues and timelyescalation as applicable.
  
• Provide QA oversight to the qualification/validation,technical transfers, regulatory approvals and commercial operations at thefacility.
  
• Review/Approval of validation/Qualification/Verificationprotocols and reports associated with new product or material entry.
  
• Helps maintain site practices and procedures related tofacility start-up, instrument qualification, usage, technology transferexecution, and commercial manufacturing.
  
• Responsibility for adhering to domestic and internationalGMP regulations, cGMP’s, company policies, leadership behaviors, andperformance and budget management.
  
• Provide support and expertise for the preparation ofregulatory submissions, inspection readiness activities, during healthauthority inspections including interaction with inspectors, responses toinspection observations, and monitoring of follow up actions.
  
• 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.
  

Education and experience requirements:

• Degree or post-graduate qualification in Science,Pharmacy or equivalent.
  
• 4+ years experience in QA.
  
• Demonstrated knowledge of Quality Management Systemtools, continuous improvement methodologies & in-depth understanding ofsite level products & related processes.
  
• Demonstrated expertise to effectively communicate withinall levels of the organization around concepts of design controls, designverification and validation activities; production & process controls;Corrective & Preventive Action (CAPA), complaints & risk management;& product quality improvement using tools such as six sigma, DFR, etc.
  
• Demonstrated collaboration, negotiation & conflictresolution skills.
  
• Excellent communication skills (written and oral).
  
• Must be able to work across a team matrix in order to meetaccelerated timelines.
  
• Demonstrated understanding of continuous quality /process improvement tools (As defined by the site, e.g. DMAIC, Lean QA, 5Setc).
  
• Experience in performing internal audits andparticipating in external audits.
  
• Exceptional analytical, problem solving & root-causeanalysis skills.
  
• Ability to multi-task and handle tasks with competingpriorities effectively.
  
• Strong technical aptitude (i.e. able to read &comprehend technical documentation & execute procedures), global regulatoryexperience & demonstrated experience interfacing with regulators.
  
• Experience with working in a multinational organisation.
  
• Strong operations support background ensuring value addedand effective quality oversight
  
• 16 = The workplace operates for 16 hours per day.
  
• 7 = The workplace operates all 7 days of the week,including weekends.
  
• Working hours: 7:00 AM to 11:00 PM.
  
• 6 Shift Cycle: The roster uses six shift/team codes (A,B, C, D, E and F) and combinations of these codes.