Sterility Assurance LeadNew

2 weeks ago

Sligo, Ireland Next Generation Full time

Sterility Assurance Lead - Expanding Biopharma Manufacturer

We are seeking an experienced Sterility Assurance Lead to join an expanding biopharma manufacturer. In this role, you will own the site's Contamination Control Strategy and ensure compliance with sterility assurance regulations.

Key Responsibilities:

Lead the site's Contamination Control Strategy. Collaborate with operations to develop a robust aseptic processing training programme . Establish the site's gowning strategy and oversee the cleaning and sanitisation programme. Monitor and analyse microbiological data to identify trends. Provide technical guidance on contamination-related non-conformances and events. Ensure compliance with sterility regulations and act as the SME for sterility assurance during regulatory inspections. Offer technical input for the transfer of microbiological test methods.

Experience Required:

Degree in a relevant technical discipline (Microbiology qualification desirable). Minimum 4 years' experience in Quality/Operations within the pharmaceutical or biopharma industry. At least 1 year of aseptic sterile fill-finish manufacturing experience . Experience in a microbiological function within an aseptic sterile fill-finish facility

  • Sterility Assurance Lead

    2 weeks ago

    Sligo, Co. Sligo, Ireland Next Generation Recruitment Full time

    Sterility Assurance Lead - Expanding Biopharma Manufacturer We are seeking an experienced Sterility Assurance Lead to join an expanding biopharma manufacturer. In this role, you will own the site's Contamination Control Strategy and ensure compliance with sterility assurance regulations. Key Responsibilities: Lead the site's Contamination Control Strategy....

  • Sterility Assurance Coordinator

    2 weeks ago

    Sligo, Co. Sligo, Ireland FRS Recruitment Full time

    Sterility Assurance Coordinator Biotech Scale-Up Join a leading biotech company in an exciting growth phase, working on the forefront of microbiology and cleanroom management currently seeking a Sterility Assurance Coordinator to lead key projects Key Responsibilities: Lead and manage cleanroom upgrades from Grade D to Grade A. Develop and implement action...

  • Sterility Assurance Lead

    4 months ago

    Sligo, Ireland TEAM HORIZON Full time

    Description Team Horizon is seeking a Sterility Assurance Lead for our Client, a global biopharmaceutical company who are committed to transforming lives & driving innovation. Why you should apply: This is an important role, and you will valued part of the quality organization and act as the owner of the sterility program for the site. You will...

  • QA Operations Manager

    4 months ago

    Sligo, Ireland TEAM HORIZON Full time

    Description transforming lives & driving innovation. Why you should apply: This is an excellent opportunity and is a high impact role where you will lead a diverse team of quality professionals that are responsible for quality operations for the site, including batch release, sterility and compliance.  Generous Salary & Benefits package, as well...