Sterility Assurance Lead – Waterford Contractor

This is a 23-month contract with our Global Biologics client in Waterford.

Purpose:

Sterility assurance support to Sterile operational area, working with new innovative technologies Developing and improving aseptic processes for recently qualified aseptic processing area Proactive assessment of regulatory and industry updates to align with best practices.

Responsibilities:

Development of and support for the implementation of strategies regarding;

• Contamination Control
• Media Fill
• Environmental Monitoring and Performance Qualification
• Decontamination, Sterilisation, and Dehydrogenation
• Management and prevention of sterility breaches such as leaks or glove damage
• Gowning for classified area
• Cleaning validation for microbial properties (bioburden/endotoxin)
• Lead major sterility assurance investigation
• Provide advice and support for significant investigations or projects related to sterility assurance, environmental excursions, or contamination concerns.
• Review documents related to commissioning, qualification, performance qualification, process validation, risk assessment, and regulatory related to sterility assurance aspects.
• Benchmarks best industry practice through networking and attendance at key industry events
• Review of specifications for consumables relating to biological indicators and product specifications regarding microbiological parameters
• Provides quarterly and annual sterility assurance updates
• Contributes to personnel qualifications program design, training, and development of individuals relating to sterility assurance relevant topics through ongoing proactive training, mentoring, and communication.
• Participates in the determination and introduction of new technologies related to sterility assurance.
• Participates in audits/inspections/visits, both internal and external focusing on sterility assurance aspects.

Minimum Qualification & Requirements:

• Honours degree in Microbiology
• Postgraduate studies as appropriate
• Minimum of 10 years experience in the pharmaceutical industry working in a project or operational support quality/validation role and at least 5 of those working in sterility assurance, aseptic processing, or microbiology based role
• 2-3 years experience in QC Micro and leadership position is desirable