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QA Officer within Sterility

Introduction


Interested to start your career as a consultant at XPE Pharma & Science? We are looking for a QA officer.


Company/Department


As a consultant of XPE Pharma & Science, you will work for the vaccine division of our client Group, is a global

vaccine research, development and production company, at the cutting edge of innovation in the fight against the most deadly infections and diseases.


Our client global production network is in the midst of becoming the largest in the entire vaccines industry; 15 production sites strategically positioned around the world manufacture,formulate, fill, pack, check and deliver over a billion doses of about 30 different vaccines.


In your department you will provide support and expertise to the operations to ensure that the Manufacturing Performance Unit applies Sterility Assurance processes (a.e. Aseptic Practices, Environmental Monitoring,

Cleaning and Sanitization, Sterilization, Media Fill) to confidently deliver products to patients with the highest sterility assurance level at an appropriate cost.


Function information


Drive and execute continuous improvement project or remediation plan related to sterility

assurance, including change control management, SOP’s review, …

 Manage relationship with aseptic operations in the context of the tasks decribed

 Identify potential quality and compliance risks and help to manage these risks through the

existing quality systems

 Performs gap analysis, system effectiveness reviews and other management reviews, as

required

 Guarantees the maintenance of the cGMPs in the area of responsibility (SOP,

documentation, audits, training, method validation)

 Ensures and supports the implementation of adequate training and practices related to

sterility assurance, including shop floor mentoring as required

 Contributes to inter-MPU QA meetings to share knowledge and practices and to review

sterility assurance issues as to foster continuous improvement and manage risks



Requirements


Required Experience & Knowledge

  • Relevant experience in sterility assurance
  • Previous experience in QA in the pharmaceutical industry
  • Experience in GxP
  • Previous experience in GSK is a strong asset

Soft skills:

  • Hands-on approach
  • Able to work on the shop floor with a coaching and mentoring style to impact individual experiences
  • Strong communication skills with all levels
  • Influencing skills
  • Builds trust and rapport with others
  • Flexible mindset

Offer


A permanent contract with XPE Group.  A package appropriate to your experience, knowing that we're looking for a MEDIOR profile (3 to 7 years concrete experience will be considered)


Information


Ready to apply?

Please send me your CV in ENGLISH and in a WORD format.

For more information call me on 010/80.71.15

Andrea



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