Group Sterility Assurance Associate - Hybrid

  • Location
    Alderley Edge, Cheshire
  • Job type
  • Industry
  • External Reference
  • Category
    Science - Science

Group Sterility Assurance Associate (Medical Device) Cheshire - Hybrid

A fantastic opportunity for a Group Sterility Assurance Associate to join a world leading independent developer and manufacturer of innovative and technologically advanced products

Role responsibilities:

Acts as subject matter expert (SME) to support all activities related to sterility assurance, providing technical expertise and guidance and support site related activities across the group. To assure necessary compliance requirements are met to applicable national/international standards related to sterilisation methods.

  • Responsible for the representation of Sterility Assurance through all product design and development life cycle phases to ensure product sterility, reliability, and cost effectiveness.

  • To determine whether sterilisation methods are deemed adequate in accordance with applicable regulations and standards (eg ISO 11135, ISO 11137 & ISO 17665) for product portfolio and expansions to product portfolio.

  • Performs reviews of updated standards and provides information for effective gap analysis of validations/procedures at site level.

  • Ensures all related QMS processes are kept up to date with latest versions of applicable standards and industry guidance. Training on applicable national/international standards across all sites.

  • Create and review documentation associated with the quality system related to sterility assurance, including but not limited to quality plans, verification/validation protocols, risk assessment documentation and updates to quality system and department procedures.

  • Supports activities associated with aspects of the Quality Management System including:

o Status of Non-Conformances, CAPAs, SCARs, Audit observations

o Participation in Material Review Board (MRB), where required

o Participation in compliance meetings (Change Control)

o Customer complaints

o Internal audits

Role requirements:

  • BS or equivalent in scientific discipline or the abilities that are typically acquired through experience in medical device or pharmaceutical industries.

  • Proficient in the knowledge of applicable Quality System Regulations and ISO quality requirements

  • Experience within sterilization and microbiology

If you are interested and would like to hear more, please contact me on 07936 035 256 OR

Adecco Lifesciences is acting as an Employment Agency in relation to this vacancy.

To speak to a recruitment expert please contact Olivia Cann