Sterility Assurance Lead
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| Job Type | Contractor |
| Area | Sligo, Ireland |
| Sector | QualityLaboratory/Scientific |
| Start Date | |
| Advertiser | Mary King |
| Job Ref | 1002878 |
| Job Views | 421 |
- Description
-
Team Horizon is seeking a Sterility Assurance Lead for our client based in Sligo on a 12-month contract. As our new Sterility Assurance Lead, you will act as SME for sterility assurance joining a talented and diverse team playing a key role in ensuring that all products leaving Biologics meet the standards required for marketed and investigational drug product.
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing:
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
Supervise team of Laboratory Technicians and Lab. Coordinators, scheduling their work, vacations, and holidays. Planning & coordinating analysis of products, raw material, in-process samples, final bulk and final product samples, and water samples
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
And other duties required
What you need to apply:
Third level qualification to degree level in a relevant technical discipline, ideally microbiology, science/engineering.
3 years supervision experience in Laboratory areas
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
Basic knowledge of governmental regulations and pharmaceutical compendia (USP, EP, BP, etc.)
Good statistical and scientific knowledge. These include laboratory troubleshooting and problem solving skills. Know and/or understand monitoring methods
