Quality Control Microbiologist

PE Global; Westport; On-site; EUR 42,000 - 60,000; Full time

Job summary

PE Global is currently recruiting a QC Microbiologist for a leading pharmaceutical client based in Westport, Ireland. This contract role involves performing routine microbiology testing, environmental monitoring of cleanrooms, and batch testing across raw materials, utilities and development batches as part of the Global Stability program.

You will work to cGMP standards, support release and stability testing, ensure timely reporting and documentation, and contribute to investigations and CAPAs

Qualifications

• 3rd Level Qualification in Microbiology or equivalent.
• At least 12 months in a manufacturing environment, preferably aseptic processing.
• Working knowledge of Pharmaceutical Industry and sterile processing.
• Strong background in Aseptics and/or Microbiology.
• Ensures testing completed within agreed turnaround times.
• Compliance with product licenses, cGMP and health & safety standards.

Responsibilities

• Environmental Monitoring
• water sampling
• bioburden
• in-process testing
• endotoxin
• growth promotion
• Sterility testing
• APET
• Antibiotic Assay
• Report writing
• Draft and review SOPs, protocols, training modules, investigations, reports, CAPAs and deviations
• Trending of results and investigations into adverse or out-of-limit results
• Validation of equipment and microbiology test methods

Skills

Microbiology

Aseptic processing

Environmental Monitoring

Regulatory compliance

cGMP

Education

3rd Level Qualification in Microbiology or equivalent

Job description

PE Global is currently recruiting for a QC Microbiologist for a leading multi-national Pharma client based in Westport.

This is a contract position.

Role:

The Microbiology Analyst is responsible for the carrying out routine microbiology laboratory activities including environmental monitoring of cleanrooms, microbial analysis of site utilities and testing of raw material, commercial, clinical and development batches. Further, the position holder will manage the microbial analysis of Allergan products included in the Global Stability program. Microbial monitoring and testing are performed in line with regulatory requirements.

Responsibilities

• Perform key tasks for release and stability testing such as:
• Environmental Monitoring
• water sampling
• bioburden
• in-process testing
• endotoxin
• growth promotion
• Sterility testing
• APET
• Antibiotic Assay
• Report writing
• Draft and review documentation –SOPs, protocols, training modules, investigations, reports, CAPAs and deviations
• Trending of results and preform investigations into adverse or out of limit results
• Validation of equipment and microbiology test methods

Requirements

• 3rd Level Qualification in Microbiology or equivalent scientific degree
• 12 months working in a manufacturing environment. Preferably Aseptic processing.
• Working knowledge of both Pharmaceutical Industry and sterile processing.
• Strong background in Aseptic’s and/or Microbiology
• Achieves a high level of competency in laboratory methods and procedures to support raw material, utility, in process, release and stability testing of sterile products.
• Performs routine and non-routine Microbiological testing activities as required.
• Ensures that all testing is completed, reviewed and approved within agreed turnaround times.
• Ensures activities are carried out in compliance with product license commitments, cGMP, company quality standards and legislative regarding health, safety and environment.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***