Research Quality Association

QA Advisor

GSK
Ware, South East England, United Kingdom
14 days ago

Description

Site Name: UK - Hertfordshire - Ware RD, UK - Essex - Harlow
Posted Date: Jun 2 2021


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.

This is an opportunity to join the Pharma Supply Quality Assurance group within R&D at GSK Harlow. You will play a critical role in ensuring the quality and compliance of Investigational Medicinal Products used worldwide in the clinical development, and trial, process. You will additionally develop existing expertise and capability within the R&D environment, identifying opportunities to improve processes and operating procedures.

From this post, you will understand the end-to-end manufacturing and supply chain process works, being exposed to a range of business areas as well as regulatory requirements. After you perform review of Manufacturing/Packaging documentation, the documentation goes to the QP for release to the clinics, meaning this position is very close to the patient and contributes directly to GSK’s mission statement of helping people do more, feel better and live longer.

This role will require excellent communication skills, utilised to build relationships and trust which allow you to engage effectively across the business. You will often face conflicting priorities, as well as both issues and stakeholders pulling up on your time, meaning you will need to be highly organised and able to deliver consistently under pressure, multitasking and balancing expectations as required. You’ll do all of your work with an exceptional attention to detail, ensuring all decisions are made based on GMP principles. This role will benefit from a proactive and a direct approach, meaning someone who is willing to take on work, to support others and to try new things is likely to excel.

Key Responsibilities

  • Reviewing and recommending release of documentation for a range of dosage form batches and finished clinical trial packs of Investigational Medicinal Products in accordance with GMP/GSK requirements
  • Assessment of Quality Deviations, customer complaints and vendor complaints and make recommendations for corrective and preventative actions
  • Continuous follow up on the implementation of those recommendations.
  • Providing advice and support to business partner areas relating to quality matters and process improvement.

Closing Date for Applications: 9th June 2021 (COB)

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.

  • LI-GSK

Why you?

Basic Qualifications

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

  • Experience of review of GMP Manufacturing and/or Packaging Documentation of a range of pharmaceutical dosage forms including sterile products within a Quality Assurance role
  • Hands on experience in a Pharma Quality Assurance role
  • Demonstrated involvement in: Quality Deviations, Customer and Vendor Complaints, Change Controls, Inspections and Audits

Preferred Qualifications

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

  • Hands on experience of batch release and batch review processes
  • Experience/Knowledge of manufacturing and packaging, with ideally a range of pharmaceutical dosage forms, including sterile products
  • Knowledge of the R&D process, particularly with respect to clinical trials manufacturing and packaging
  • Hands on experience in Investigations and Root Cause Analysis

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.

Please don’t hesitate to contact us if you’d like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on 0808 234 4391, or send an email ukdiversity.recruitment@gsk.com

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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.



Job Information

  • Job ID: 57269654
  • Location:
    Ware, South East England, United Kingdom
  • Position Title: QA Advisor
  • Company Name: GSK
  • Job Function: Quality Assurance
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