QA Compliance Microbiologist

HIRANI; Newry; On-site; GBP 35,000 - 48,000; Full time

Job summary

HIRANI is recruiting a QA Compliance Microbiologist to oversee cleanroom compliance, gowning, aseptic technique and environmental monitoring in classified facilities. The role supports training, evaluations and continuous improvement within our aseptic cleanrooms.

Key duties include inspections, risk assessments, remediation actions, SOP reviews and collaboration with audits. A degree in a biological sciences or engineering field with relevant cleanroom experience is required, with strong

Qualifications

• Degree or higher in a biological science or engineering field with GMP exposure.
• Candidates should have at least 2 years in a high-grade cleanroom environment.
• Strong attention to detail and ability to generate reports in MS Office.

Responsibilities

• Oversee cleanroom compliance, gowning, aseptic technique and environmental monitoring.
• Support training, evaluation and continuous improvement projects in aseptic cleanrooms.
• Lead or participate in audits and inspections with regulatory and customer teams.
• Review SOPs and maintain technical documentation in line with GMP.
• Identify deficiencies, assess risk, and support remediation actions and investigations.

Skills

GMP knowledge

Quality documentation

Microsoft Office

Education

Degree in biological sciences or engineering

2+ years cleanroom experience

Tools

MS Office

Job description

We are currently recruiting for the role of QA Compliance Microbiologist within the QA Cleanroom Compliance department. The successful candidate will provide quality oversight to ensure adherence to all aspects of cleanroom behaviours, gowning, aseptic technique, cleaning & disinfection, transfer procedures and facility standards for classified cleanrooms in line with regulatory requirements. The successful candidate will also support with training, evaluation and continuous improvement projects within our aseptic cleanrooms.

Main Activities/Tasks

Work closely with cleanroom team to ensure alignment with best aseptic practices, standard operating procedures and GMP requirements.

Participating in regular cleanroom inspections to promote continuous improvement and compliance.

Quickly identifying and documenting all deficiencies found during cleanroom inspections and support with assessing risk to product.

Initiating and supporting remediation measures and investigations required in response to the cleanroom inspections finding and environmental monitoring trends.

Arrange & deliver initial training for personnel working in the classified cleanroom environment.

Arrange & deliver periodic re-training in line with SOP & regulatory requirements and/or in response to environmental monitoring trends.

Assisting in the reviewing and compilation of Standard Operation Procedures and other technical documentation in line with current GMP and regulatory requirements.

Support with the selection and validation of new cleanroom cleaning, disinfectant, cleanroom consumable products e.g., mops, wipes, garments, stationary.

Provide technical support for new and upgraded classified cleanroom facilities and cleanroom equipment.

Support simplification & efficiency initiatives.

Participate in customer and regulatory audits.

Be flexible to take any other duties as required by Management.

Applicants must therefore demonstrate the following essential criteria on their application form be considered:

Educated to at least Degree level or equivalent in a biological science or engineering field or have minimum 2 years’ experience within a high-grade cleanroom environment.

Excellent attention to detail and highly organised.

Strong computer skills and proficient in the use of Microsoft Office with the ability to generate reports.

Flexibility to work a shift pattern which may incorporate nights and/or weekends.

Excellent oral and written communication skills.