Sterility Assurance Lead

Role Summary:

• Reporting to the QA Manager, the successful candidate will be responsible for oversight and development of all sterility assurance activities on site as well as the development of sterility assurance and contamination control strategies.

Core Duties and Responsibilities:

• Development of and support for implementation of strategies regarding:
• Contamination Control
• Media Fill
• Environmental Monitoring and Performance Qualification
• Decontamination, sterilisation and Depyrogenation
• 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 investigations
• 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.
• Benchmark 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 programme 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 Qualifications and Experience:

• Honours degree in Microbiology or a related discipline
• Post Graduate studies as appropriate
• Significant experience in sterile pharmaceutical manufacturing and sterility assurance.
• Experience supporting regulatory inspections
• Strong technical writing, report writing skills.
• Ability to collaborate effectively across cross-functional teams.

Please note, we do not require agency assistance with this role.