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Job description

The Biopharm Central Testing Laboratory (BioCTL) is based at GSK's flagship Research and Development (R&D) site at Stevenage (Hertfordshire) and is key component of GSK's manufacturing and supply organisation. The BioCTL performs release and stability testing for a range of Biopharm clinical and commercial products and also has responsibility for oversight of external contract testing. The BioCTL performs a range of physico-chemical and bioassay techniques and also provides technical expertise to the wider GSK organisation for these assay platforms.

Job Purpose:
As a Quality Assurance Specialist, you will ensure that the BioCTL complies with all Quality Management Systems (QMS) and relevant regulatory standards in relation to data generation and laboratory testing (and approval).

Day to day, your role will include maintaining relevant GxP training compliance requirements (supporting delivery of training courses and relevant learning material) and ensuring compliance with method Standard Operating Procedures (SOPs). This will be achieved by performing real time GEMBA/process confirmation during assay execution and data integrity pathway reviews. You will initiate and coordinate deviation and change control notifications in the relevant (SAP) system, complete change control tasks as required, participate in root cause analysis for deviations, customer and service complaints (as QA representative) and perform department's self-inspection (L1) and audit reviews (maintaining associated schedules and documentation).

You will take ownership of quality systems (e.g. deviations, change controls), Control Printing, Reconciliation Process and site Curricula Review Process (including provision of metrics) and report program trends on a periodic basis and review, as well as initial approval of notifications (in SAP). You will manage the archiving for all documentation (both on and off-site), including maintaining the validated document register (organizing and filing paperwork in line with local procedures and requirements, as well as retrieving and returning archived documentation as required).

You will assist in the preparation for and participate in regulatory agency inspections and monitor L2 audits (including audit readiness assessments as required). In this capacity you will also provide support to the site Compliance team by performing activities such as reviewing and responding to Quality Alerts and maintaining the GMP training schedule. Throughout you will manage the BioCTL's Records Retention Schedule and act as Records Champion.

About You:
This role would suit a self-motivated individual who has strong experience of working in a laboratory quality control environment. You will be degree-educated in a relevant life-sciences subject with a solid base-level of technical knowledge and analytical skills in relevant laboratory procedures, processes and techniques (ideally obtained from a pharmaceutical testing environment). You will be resilient and calm under pressure. Strong people-skills and a proven ability to influence people to achieve objectives and drive performance are considered fundamental to the role. You will also have a strong continuous improvement mindset, and a demonstrable ability to prioritise and make decisions.

About Stevenage R&D Site:
GSK's Medicines Research Centre at Stevenage is a major R&D facility for the company, acting as a center of excellence for research into Respiratory, Inflammation and Respiratory conditions. It has also been designated a satellite site for the company's research into Neurology / Cardio-Vascular diseases. The site employs over 3,000 people and is at the heart of GSK's global efforts to develop new medicines.

Applicants are asked to demonstrate in their application how they meet the above criteria in order to be successful for interview selection.

CLOSING DATE for application: Friday 28th of June 2019 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.

Why You?Basic qualifications:
• Relevant experience of working in a highly regulated technical industry.
• Relevant qualifications in scientific discipline.

Preferred qualifications:
• Experience working in a GMP regulated environment in a role directly related or supporting Quality or Manufacturing (Laboratory experience preferred).
• Quality assurance experience in either a manufacturing setting or a laboratory setting.

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

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

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.

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