Sterility Lead

A Sterility Assurance Lead is required by Careerwise Recruitment to join a leading pharmaceutical company based in Waterford. Reporting to the QA Manager, you will play a key role in ensuring the highest standards of sterility assurance, contamination control and cGMP compliance across the site. This is a 12-month contracting position.

Responsibilities

• Leading and developing site-wide sterility assurance activities and strategies
• Developing and supporting contamination control strategies
• Providing expertise across Media Fills, Environmental Monitoring, Performance Qualification, decontamination, sterilisation and depyrogenation
• Managing and investigating sterility assurance events and potential breaches, including leaks and glove damage
• Supporting gowning, cleaning validation, bioburden and endotoxin control
• Providing expert advice on significant investigations, environmental excursions and contamination concerns
• Reviewing and contributing to documentation relating to commissioning, qualification, validation, risk assessment and regulatory compliance
• Keeping the organisation up to date with industry best practice and emerging technologies
• Supporting specifications for biological indicators and microbiological parameters
• Providing quarterly and annual sterility assurance updates
• Developing and delivering training, mentoring colleagues and supporting personnel qualification programmes
• Participating in internal and external audits, inspections and regulatory visits

Requirements

• An Honours degree in Microbiology or a related discipline
• Postgraduate studies in an appropriate field would be advantageous
• Strong experience in sterility assurance, microbiology and contamination control within a GMP-regulated environment

Please call Louise Mulligan today for further information on 0949003979 or email: lmulligan@careerwise.ie

CareerWise Recruitment (In Search of Excellence)

Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. 

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

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