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Sterility Assurance Consultant

  1. East
Maastricht
  1. Contract
Competitive
  1. Compliance / Quality Assurance
09-03-2021
26269AST

This vacancy has now expired

One of our global bio-pharmaceutical clients based in Holland is looking for a Sterility Assurance Lead to support them with the implementation of the Sterility Assurance Program which will include the preparation / leading the Sterility Assurance Board, support of programs like Aseptic Processing Program, Clean room Principles and Environmental Monitoring for the site.

Summary:
  • This individual should be able to work independently with little direction to review policies and procedures and related completed APS documentation, Environmental Monitoring sample plans, clean room qualifications, Environmental Monitoring excursions, deviations, and sterility failures. 
  • Review of sterile filter validations, integrity testing and procedures is also required.
  • The individual is expected to interact with site Operations Management, QC and QA leadership. 
  • Primary responsibility is to maintain sterility assurance of aseptically manufactured sterile drug products and viral vector products.
Job Description:
  • Develop, document, and support microbial control strategy for production processes from incoming raw materials through final product release.
  • Can provide guidance, oversight and support for Operations and QA/QC specialists.
  • Provide oversight and sterility assurance expertise to Operations to assure aseptic processing meets US and international aseptic processing requirements (FDA Sterile Product Aseptic Processing Guidance and EudraLex, Annex 1,” Sterile Medicinal Drug Products”, ISO 13408 and 21CFR820).
  • Assesses facility and quality systems’ state of compliance with internal requirements and appropriate regulations and participates in the development of action plans to correct deficiencies and improve quality processes.
  • Provides microbiological expertise to support EM deviations and investigations, CAPAs and Complaints related to aseptic processing.
  • Supports regulatory and client audits as Aseptic sterility assurance subject matter expert.
  • Provides microbiological and sterility expertise for cGMP documents including, but not limited to, SOPs, batch records, APS protocols and reports, validations, specifications, and risk assessments.


The candidate must have the rights to work in the location stated in the job advert.

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