Sterility Assurance Manager

Contract: CDI, permanent
Location: Roncq (59), France

At TISSIUM, we are creating the future of tissue reconstruction. Our team pushes the limits every day to design next-generation products based on our platform of biomorphic programmable polymers. We are disrupting the field of surgery, both open and minimally invasive, to positively impact the lives of patients.

We are actively looking to recruit a Sterility Assurance Manager to be part of Tissium’s Development Factory. This person will guarantee the conformity of the aseptic process by managing and improving it to ensure that:

  • The QMS is in compliance with all applicable aseptic standards and regulations;
  • All production activities are in compliance with the company’s QMS;
  • All released batches are conforming.

Duties & Responsibilities

  • Manages continuity and compliance of the QMS to applicable aseptic standards and regulations.
  • Manages compliance with the QMS for all aseptic production activities by:
    • Participating to medial fill test strategy definition and to periodic media fill tests;
    • Participating to aseptic training process of the personnel;
    • Ensuring that only qualified persons participate to the aseptic process;
    • Ensuring environmental control of cleanrooms and products;
    • Ensuring that all site aseptic batch records anomalies are identified and investigated and that only conforming products are released;
    • Ensuring that production documentation is adequate;
    • Managing the aseptic risk assessment activities;
    • Ensuring support to the different departments.
  • Participates to global risk assessment activities;
  • Ensures that sterilization processes (internal and sub-contracted) are compliant with applicable standards and regulations.
  • Participates to CAPA, NC and Change Control processes to guarantee the continuous improvement of the QMS.
  • Performs raw material, semi-finished, final product batch release and sterilization release.

Qualifications & Skills

  • Engineering Degree or equivalent;
  • Five years minimum experience in aseptic production processes;
  • Experience in Quality in a pharmaceutical company and in a production environment;
  • Working knowledge of GMP annex 1, FDA Sterile Drugs Produced by Aseptic Processing, ISO 13408 and FDA (FDA 21 CFR part 820) regulations;
  • Good knowledge of sterilization processes:
  • Good communication skills (both oral and written) in English;
  • Competent in interactions with executive management, regulators and suppliers.

Job Competencies & Personal Attributes

  • Autonomous and detailed oriented;
  • Dynamic and proactive;
  • Able to understand complicated processes and understand the associated documentation needs;
  • Disciplined and very well organized;
  • Persuasive and diplomatic.

The Sterility Assurance Manager will report to the Head of Quality. The position is based in Roncq, France. To apply to this position please email your CV to REF 202009-002