|Role Type||Fixed Term Contract|
Sterility Assurance Lead
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.
- 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/ firstname.lastname@example.org
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