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Job

QA Manager

  • Location

    Belgium

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Contact:

    Luisa Namadila

  • Contact email:

    l.namadila@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    about 1 month ago

  • Expiry date:

    2021-01-03

Hamlyn Williams have partnered with an internationally recognized biopharmaceutical company who are going through a rapid phase of growth. The company specializes in the treatment of severe diseases with specific areas of focus within neurology and immunology disorders.

As a result of company growth, we are looking to fill a QA Manager position on a perm basis. This will be an independent role as part of a growing and dynamic quality assurance team, reporting directly to the Head of Biologics.

** English speaking role **

Responsibilities will inlcude:

  • Approve all operational procedures/instructions specification & master production instruction with the potential to affect the quality of the product.
  • Review & approve of validation protocol & reports, study protocol & reports to support Capital or key site projects as required 
  • Making sure that there is stability data to support retest or expiry date, storage conditions
  • Support inspections and audits from external parties (e.g. FDA, IMB, EMEA or alliance partners).
  • Participating in internal audits as required
  • Participate in the preparation/review of regulatory dossiers. 
  • Establish and maintain support and key liaison representative with Third Party Managers
  • Oversee key quality systems such as (CAPA /ER report system, Change Review Board system etc..)
  • Ensure that all parts of the QMS are adequately resourced with competent personnel and suitable / sufficient premises and equipment.
  • Ensure continued and adequate supplies to the market, such that the patient needs are covered and that any anticipated restriction in supply is escalated to the relevant competent authorities in a timely manner

Specific requirements for this position:

  • Biologics background 
  • QA experience-minimum of 5 years

Attach an updated CV to be considered