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WD141998 - Batch Certification and Quality System Lead

Job Details

  • Permanent, Full Time
  • Middlesex
  • Closes 15th December 2017
  • Requisition ID: WD141998
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Basic qualifications:

• BSc, MSc or PhD in a related scientific discipline such as chemical engineering, chemistry, analytical chemistry, or Biochemistry.
• Competent in the development and deployment of quality processes
• Detailed knowledge and understanding of pharmaceutical quality management systems and EU GMP
• Demonstrated aptitude for managing multiple tasks and priorities
• Demonstrated ability to work effectively in cross functional Team environment

Preferred qualifications:
• Certified EU QP qualification is preferred

Who are we?

At GSK we are a science-led global healthcare company. We research and develop a broad range of innovative products in three primary areas of Pharmaceuticals, Vaccines and Consumer Healthcare. Our mission is inspiring and challenging – to help people do more, feel better and live longer.

We have a significant global presence with commercial operations in more than 150 countries, a network of 86 manufacturing sites in 36 countries and large R&D centres in the UK, USA, Spain, Belgium and China.

Job Purpose:
This role is a high impact role leading required changes to Quality Management Systems across the supply network and influencing across a broad spectrum of people. The role will lead the program of activity to deliver Quality System changes required for an operating model meeting future GMP needs for manufacturing and supply. The key interfaces will include Quality Professionals across the Global Manufacturing and Supply network and cross function subject matter experts. This role will be responsible for key quality systems requirements (e.g. material controls, QP certification, etc.) in addition to supporting process development for non-Quality System process (e.g. supply planning).

Communication skills are very important as interactions with cross-functional teams at the site level and across the GMS network will require multiple communication modes and techniques. Project management experience to ensure the management and tracking of transformational activities will be required.

Key Responsibilities:
• QP Batch Certification and Knowledge Transfer Lead
• Ensures standard approach is utilised to deliver and demonstrate compliance with UK and EU regulatory requirements for batch certifications activities
• Contribute to risk management process as a SME for batch certification and quality systems, developing and managing mitigation plans Material control process definition and implementation
• Quality system impact assessments and detailed action plan owner, working with sites, logistics, functions and LOC quality
• Support process review and change requirements for key product flow processes collaborating with Supply and other support functions

What do we offer?
At GSK we are all inspired by the difference we make and challenge ourselves every day to improve the lives of patients and consumers. That’s why we have created an environment where everyone feels valued, able to develop, contribute to our mission and be proud of what we achieve.

To support you in achieving your role and career ambitions you’ll be given the opportunity to:
• Play an important role in delivering our mission
• Be an essential part of diverse, global team
• Develop others as part of your own professional growth

You’ll also receive a competitive salary package including on target bonus, shares, private medical insurance, Company Pension Plan, 26 days annual holiday, private healthcare option, bonus scheme and a share purchase scheme plus a personalized career development pathway.

Please note this role is based at the GSK House and is for a 18 Month Fixed Term Contract (FTC).

During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.

If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.

Closing date for applications: COB – 15th December 2017

When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.

The information that you have provided in your cover letter and CV will be used to assess your application.

Thank you for your interest in this opportunity.


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

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