Job ID: JOB-11477
Sterility Assurance Lead

My client a North West based Biopharma company with sites around the world is now recruiting for a Sterility Assurance Lead, to join the Biologics start-up Operation in Sligo, on a 1 year fixed term contract basis.

As the Sterility Assurance Lead, you will act as SME for sterility assurance joining a talented and diverse team during this exciting phase of the business.

Reporting to the Quality Assurance Manager, you will play a key role in ensuring that all products leaving meet the standards required for marketed and investigational drug product.

Key Responsibilities:

• Take ownership of the site’s Contamination Control Strategy
• Work closely with the operations group to develop a training program for aseptic processing
• Provide training in aseptic behaviours and principles to the site
• Partner with the QC Micro Lab to develop the clean utilities and environmental monitoring program for the site
• Establish, in conjunction with the operations function, the sites gowning strategy and cleaning and sanitization program
• Monitor and review microbiological data to detect trends
• Liaise with the global science and technology team to ensure best practices are in place concerning sterility assurance
• Provide technical guidance on any contamination related to non-conformances or events.
• Ensure that the site is operating under governing regulations for sterility assurance
• Collaborate with cross-functional teams for the transfer of microbiological test methods to the site
• Maintain and develop site practices for contamination control etc. utilizing training and a purposeful presence on the operations floor
• Influence operations area owners to ensure that quality issues are identified, and appropriate corrective actions are implemented to maintain compliance
• Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities.
• Adhere to and follows all procedures, policies, and guidelines ensuring compliance with cGMP and HPRA/FDA regulations and company policies, procedures and guidelines

Education & Technical Skills

• Third level qualification to degree level in a relevant technical discipline, ideally microbiology, science/engineering.
• Minimum 5 years’ experience in the pharmaceutical industry or biopharma industry in a Quality/Operations role
• Minimum 1 years’ experience in an aseptic sterile fill-finish manufacturing environment
• Minimum 1 years’ experience in a microbiological function in an aseptic sterile fill-finish facility
• Proven ability to work cross-functionally.
• Strong knowledge of regulatory requirements is required.

For further information on this role please contact Clara Burke on 086 816 8273/ science@hero.ie



Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/



Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Clara Burke

JOB-11477