Job description

About PSC Biotech

Who we are?
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Description:

Microbiology Analyst

The Scientist 1 Microbiology and Scientist 2 Microbiology roles are responsible for:

• Assuring that non-conformance investigations, laboratory investigations and quality systems are in compliance with the good manufacturing practices.
• Good laboratory practices as established in the code of local government regulations and company procedures.
• Report to QA Microbiology Lab Supervisor.

DUTIES & RESPONSIBILITIES

List main areas of responsibility:

• Perform routine environmental monitoring, product testing in line with company and regulatory specifications and trend associated data.
• Perform routine testing on water purification systems in line with company and regulatory specifications and trend associated data.
• Perform Quality Control on incoming media and test kits.
• Perform microbial identifications to ensure compliance with procedure and regulatory requirements.
• Perform validation and annual re-qualification of production Sterilisers and calibration of Validation equipment and document-associated data.
• Complete Annual re-qualification of laboratory Steriliser.
• Perform Process / Equipment / Facilities and Utilities Validation and document associated data.
• When required, Review and report Steriliser Non-conformances.
• Perform monthly run review of production sterilisers performance using statistical tools.
• Implement improved methodologies/processes for Lab processes.
• When required Perform microbiology assessment on engineering changes.
• Carry out safety inspections.
• Training of new microbiology laboratory technicians.
• Providing Japan Distribution with Sterility Certificates for product.
• Ensure Lab is supplied with consumables.
• All employees are responsible for minimizing both the Environmental and Health & Safety effects of the work that they perform.
• Creating, implementing and assessing change requests.
• Sterilizing and disposing of laboratory waste.

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Requirements

EXPERIENCE & EDUCATION

Desirable:

• Good knowledge of FDA and ISO requirements
• Good organization skills and familiarity with computer packages.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES AND AFFILIATIONS

• No specific required knowledge, skills, abilities, certifications/ licenses, or affiliations are required for these roles.

#LI-BR1

Job Type: Full-time

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Limerick, County Limerick: reliably commute or plan to relocate before starting work (required)

Reference ID: 12870

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