Qualified Person - QP, Open to flexible working

Location
Harlow, Ware
Salary
£Competitive
Posted
17 Apr 2021
Closes
10 May 2021
Ref
287216
Contract Type
Permanent

GlaxoSmithKline is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to support our mission to improve the quality of human life by enabling people to do more, feel better and live longer.

An exciting contract opportunity has arisen for a Qualified Person (QP) to join the Pharma Supply Quality Assurance group within GlaxoSmithKline Research & Development. 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).

Key Responsibilities

  • 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.

Please take a copy of the Job Description, as this will not be available post closure of the advert.

When applying for this role, please use the 'cover letter' of the online application or your CV 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.

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.

Why you?

Basic Qualifications

We are looking for professionals with these required skills to achieve our goals:

  • Must be eligible to act as a QP for Investigational Medicinal Products, as defined by The Medicines for Human Use (Clinical Trials) Regulations 2004 under permanent provisions
  • Experience working with oral solid dosage forms, including capsules and tablet formulations and /or inhalation products including non-sterile liquids and suspensions
  • Strong decision-making skills based on GMP requirements
  • 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

If you have the following characteristics, it would be a plus:

  • Experience of sterile products
  • Knowledge of product development particularly IMP specific GMPs
  • Experience of packaging activities relating to finished clinical trial packs of Investigational Medicinal Products

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

  • Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning.
  • Sustaining energy and well-being.
  • Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness.

At GSK, we're a company with a special purpose, to help people do more feel better and live longer. Realising our purpose starts with us. When we feel at our best, we perform at our best.

When you set out on your adventure at GSK, we make a deal. You commit to living GSK's values and expectations and performing against our Innovation, Performance and Trust priorities. And in return, GSK commits to providing the right environment for you to thrive. Put simply, it's about you being motivated to do your best work, in a place where you can be you, feel good and keep growing.

Together we build an environment where we can all thrive and focus on what matters most to each of us. It is only through the energy, dedication, drive and passion of all of us that we can be the very best for GSK, and importantly, for our patients and consumers.

As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

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