Specialist Validation

Basic qualifications:

  • University degree in Engineer in Chemistry, biochemistry, or agronomy or Pharmacist
  • At least 2 years' experience in aseptic processing, vaccine production, quality control or quality assurance.

Preferred qualifications:

  • Knowledge of International standards (CFR and Eudralex), GMP and Regulatory
  • Knowledge in the Validation Life-cycle process as well as in Specific Validation Strategies (i.e. Cleaning Validation, Aseptic Media Simulation…)
  • Good organizational skills
  • Results oriented
  • Proven ability to work cross-functional teams and projects to obtain desired business objectives
  • Good analytical and problem-solving skills
  • Strong communication skills. Proven ability to communicate effectively with different departments
  • Fluency in English, including presenting and negotiating

Details:

Job Purpose:

  • Coordinate and operate validation activities (Validation plan, installation qualification, operational qualification and performance qualification).

Key Responsibilities:

  • Responsible for the coordination of a defined part of the validation of New HAV Project
  • Responsible for ensuring the coordination (planning, weekly validation committee participation).
  • Ensure correct and state of the art Validation approaches, be responsible, with the coaching of his N+1 or a colleague, to establish, to review and update the Validation Master Plan.
  • Responsible for the implementation of the validation policies for the processes & equipment (Validation life-cyle process, Qualifications, Process Validation) with the coaching of his N+1 or a colleague.
  • Responsible for participating, for validation sections, in external authorities inspections (EMEA, FDA, WHO…) with the coaching of his N+1.
  • Responsible for the implementation of adequate validation strategy in compliance with FDA, EMEA and International quality standards.
  • Responsible for assuring inspection readiness – regarding Validation with the coaching of his N+1
  • Act as a key interlocutor in his/her discipline between the MPU and other services (TS / Validation / QA / RA)
  • Act as the MPU representative in transversal and/or technical projects.
  • Continuously anticipate potential improvements of current processes with assuring the compliance with existing standards.

Our Offer:

At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best. GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish. GSK is an equal opportunity employer.

The Department:

Once our pioneering treatments have been developed, they are manufactured to the highest standards and distributed across the regions that need them most. Accomplishing this as efficiently and quickly as possible can quite literally be a matter of life and death. So it's no wonder that more than 70% of our talented workforce is based within Global Industrial Operations - the essential business unit that manufactures and manages the entire vaccine supply process, from customer order to product dispatch on a global scale.

As the name suggests, it operates in a multi-national context across more than 17 sites around the world, working closely in tandem with colleagues from a variety of disciplines and professions.

The department is structured in operating units that focus on various aspects of the manufacturing and supply process. These include Industrialisation (overseeing the transfer of production from R&D to a commercial level), Supply Chain Management and Technical Services.

Our Company:

GSK is one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

GSK Vaccines is one of the world's leading vaccine companies, with a comprehensive portfolio of 39 vaccines for infants, adolescents and adults and 15 more in development. We have more than 16,000 people working worldwide to deliver nearly 2 (1.9) million vaccines every day to people in around 90% (172) of the world's countries.

For further information, please visit www.gsk.com.

  • LI-GSK

Contact information:

You may apply for this position online by selecting the Apply now button.

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