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QP (Certified) - Operational QA
  • Requisition ID: WD202724
  • Position: Full time
  • Open date: Jul 3, 2019 3:00 PM
  • Functional area: Regulatory
  • Location:
    Harlow, Essex
  • Required degrees: Not Indicated
  • Relocation: No

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Your Responsibilities:
We have a fantastic new career opportunity for an experienced Qualified Person (QP) to join the Pre-Clinical Quality Assurance group within GlaxoSmithKline Research & Development based at Harlow (Essex) but also supporting the wider network.  

This is a great opportunity for a Certified QP with strong direct QP experience to develop their long term and rewarding career with GSK, a world leading global healthcare company that enables people across the world to do more, feel better and live longer.

As a QP, you will have a critical role in assuring quality and compliance to our patients through the certification and release of manufactured, assembled or imported investigational medicinal products (IMPs).


What will the role look like?

You will be primarily based at the GSK R&D main Packaging site at Harlow. However, there is an expectation that the role would also include some QP Certification of finished IMP at GSK sites in Ware and also in Dublin. There will also be the potential to work in CUC Cambridge.

This role is for an experienced QP who is looking to gain IMP experience within a global QA team in a world class organisation. Working with multiple functional areas, the role requires building strong working relationships to collaborate with colleagues to deliver IMPs to meet patient and regulators requirements.


Day to Day responsibilities will include:

• Undertake QP responsibilities for certification and release of intermediate and finished IMP in compliance with GMP, Manufacturing Authorisation, Clinical Trial Application and regulatory requirements.
• Interpretation and communication of GMP regulatory requirements to staff and customers including Investigational Medicinal product specific GMPs and their interface with GCPs.
• Review and approval of non-conformance including deviations, customer complaints, out of specification investigations.
• Review and approval of control documents e.g. SOPs, quality agreements, Packaging records.
• Involvement in internal, customer, regulatory inspections/audits as required.
• Leading quality improvement and / or change activities in support of business objectives.
• Provide advice and consultation to resolve significant Quality issues
• Work directly with regulatory Authorities such as HPRA and MHRA


Interested in Applying?

Please note this is a permanent role will be based at our site in Harlow, Essex.

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 – Wednesday 17th July 2019.

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.

*LI-GSK


Why You?

Basic qualifications:

• Must be eligible to act as a QP for Investigational Medicinal Products / Medicinal products, as defined by The Medicines for Human Use (Clinical Trials) Regulations 2004, under permanent provisions
• Strong demonstrable experience in a GMP quality role within the pharmaceutical industry.
• Experience working with oral solid dosage forms, including capsules and tablet formulations and /or inhalation products including non-sterile liquids and suspensions and  / or Biological products.
• Strong decision-making skills based on GMP requirements.
• Able to demonstrate leadership, coaching and mentoring skills across multiple functions.
• Strong communication skills with the ability to work in a team building relationships and trust.
• Able to work calmly under pressure in an environment where a range of issues will pull upon your time and where there can be conflicting priorities.


Preferred qualifications:
• Knowledge of product development particularly IMP specific GMPs.
• Experience of packaging activities relating to finished clinical trial packs of Investigational Medicinal Products.
• Experience of internal self-inspections and / or external audits of third parties.
• Experience of Regulatory Inspections.
• Delivery of quality improvement projects.


Why GSK?:
GSK is a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. Our products are used by millions of people around the world, helping them to do more, feel better and live longer. Employing over 100,000 people globally, we have 71 manufacturing sites around the world.  For more information on GSK please refer to our website:  www.gsk.com

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.

HOW DO I DEVELOP MY CAREER?
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 will also have regular personal development meetings with your line manager to give you the opportunity to create a fulfilling career at GSK.

HOW WILL I BE REWARDED?
The Total Reward Package offered is:
• Competitive Salary
• Car Allowance
• Competitive On Target Bonus (18%)
• 26-days paid holiday (and additional holiday purchase option)
• Personal Healthcare (with the option to purchase family cover)
• GSK Pension
• Share Purchase options
• Share & Save Schemes
• Total Reward Discounts


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

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