R&d Qp Release Manager - Rixensart, België - GSK

GSK
GSK
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Rixensart, België

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Sophie Dubois

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Sophie Dubois

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Beschrijving

Site Name:
Belgium-Rixensart


Posted Date:
Mar

The QP Release Manager will ensure support to the R&D QP Office for all release related questions for clinical lots

The QP Release Manager is a key interface between Q4R&D, TRD GMP, TRD, Regulatory, Clinical, Medical, GIO, Global functions.


The QP Release Manager will be the "voice" of the Qualified Person in any governing bodies either at local or global level.


R&D QP Release Manager

In this role you will

  • Support QP related activities in case of Issue management, recall and complaint.
  • Ensure the Product Specification Files edition and support the system in order to ensure that materials used in Clinical Trials are ordered, manufactured and released following approved Product Specification File (PSF).
  • Ensure and engage for review and effective execution of the Regulatory Submission Building Process (RSBP) and act as liaison between TRD GMP/TRD GMP Quality and GRA for any regulatory related questions (including questions on Change Control/Deviation/PSF).
  • In his area of responsibilities, ensure critical issues are adequately managed; ensure identification and characterization of the issue, impact evaluation on quality, safety and efficacy of GSK products and potential impact on clinical data as well on GSK business; ensure timely escalation to upper management including remediation plan proposals.
  • Ensure the R&D release systems and QP related systems are fit for purpose and allow release of raw materials, intermediate products and final products for clinical use in compliance with Good Manufacturing Practices, Product Specification File and Regulatory Requirements. Ensure its continuous improvement and efficiency for both manufacturing & Supply and ARD GMP departments. Manage Expertise and training within the quality release teams to ensure compliance with the latest state of the art standards and industry practices.
  • Represent QP/QA department positions/opinions views in all meetings related to the area of responsibility (staff meetings, deviations, CAPA, CC followup meetings).
  • Support the nominated QP on a daily basis in all quality issues, QP related matters and QP related activities as needed.
  • Be a QP deputy and act under the 18IMP license in case of unavailability of the nominated 18IMP QP
  • Proactively identify and manage potential quality and business risks. Educate and influence by his behavior compliance to good quality practices.
  • Is a key spokeperson front line during regulatory inspection

_ This job opportunity is a permanent contract __not_
_ opened for relocation. _

_Why you? _


Qualifications & Skills:

  • 810 years in the Pharmaceutical/Biotech industry with significant experience of GMP within a major authority jurisdiction (EMA/FDA).
  • 58 years in a quality management position with additional experience in production and/or quality control
  • Deep understanding of the framework within which a pharmaceutical product has to be developed, registered and launched.
  • Indepth knowledge and understanding of international legislation and regulatory standards.
  • Expertise recognized in several fields related to release system
  • French speaker while being fluent in spoken and written English.
Preferred

Qualifications & Skills:

  • Ability to communicate complex information both orally and in writing.
  • Ability to listen effectively.
  • Ability to drive change.
  • Ability to evaluate product compliance and quality issues and make sound recommendations regarding problem resolution.
  • Has the technical competencies to evaluate investigations, product issues,


  • Strong presentation skills

  • Capability to present in front of a national and international panel.
  • In depth understanding of cGMPs and regulations applicable to the Vaccine industry in the relevant countries. (FDA/EU/WHO and other countries)
  • Ability to adapt, work under uncertainty and accommodate flexible work demands.
  • Global perspective
  • Cultural sensitivity.
  • Selfmotivated
  • Sense of urgency.
  • Integrity.
  • Li-GSK
GSKTechTalent


_ Why GSK?_:


GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive.

Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people.

While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive.

We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be.

A place where they can be themselves - feeling welcome, valued and included. Where they can keep growing and look after their wellbei
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