Role:
QC Microbiologist
Location:
Fully on site in Dundalk, Ireland
Contract:
Until June **** (with possibility of extension)- Full-time, 39 hours weekly
Company:
A Global Pharmaceutical Company
Role Overview:
Reporting to the Microbiology Lead, this role provides real-time QC oversight for Drug Substance/Drug Product manufacturing.
It is a key position within Quality, directly supporting daily manufacturing activities to ensure compliance with cGMP and corporate/local SOPs.
Key responsibilities
Provide QC support for technology transfer and commercial manufacturing operations.
Review SOPs, risk assessments, change controls, and related documentation for DS/DP operations.
Lead/participate in microbiology projects: microbial method validation and testing, environmental monitoring, organism identification, facility qualification, cleaning validation, and process validation.
Perform microbial testing; support atypical/OOS investigations; drive/track change controls and CAPAs.
Monitor and trend method performance with supervisors and cross-functional partners.
Author technical documents: methods, protocols, validation/qualification plans and reports, SOPs.
Offer technical guidance and assess/introduce new microbiology technologies.
Support the Microbiology Lead in developing microbial control strategies, quality enhancements, and operational efficiency improvements.
Communicate effectively and take a lead role in project management interactions with internal and external stakeholders (e.g., Quality Assurance, Regulatory Affairs, Analytical Development, clients).
Serve as a primary point of contact for project coordination, including emails and client meetings.
Prepare for and participate in regulatory inspections (e.g., FDA, EMA) and client/internal cGMP audits.
Perform all tasks in compliance with applicable regulations, international standards, and company policies and SOPs.
Other duties as assigned.
Education
BSc in Microbiology or a related discipline.
1–3 years of relevant industry experience.
Work experience
Experience in a highly regulated environment.
Ability to interpret technical documentation.
Working knowledge of cGxP requirements and regulations.
Practical problem-solving skills, including formal root-cause tools (e.g., Ishikawa, FMEA).
Professional knowledge
Microbiological testing and peer review.
GMP compliance and inspection readiness.