• Job Description

  Req#: 385063

  The Quality function promotes quality and compliance through the product life-cycle within the wider manufacturing and production operations at the GSK Ware Manufacturing Site. This entails monitoring all quality related systems, improvement procedures and documentation (including analytical data and information), ensuring that products released have been manufactured, packaged and distributed according to all Regulatory and cGMP requirements (including appropriate certification for EU markets).

  Job Purpose:

  Reporting to a Quality Operations Manager, the Quality Manager on Shift (Operational QA) ensures that activities related to both manufacturing and non-manufacturing areas are carried out compliantly with SOPs and GMP and the impact on product quality and supporting quality systems is fully assessed and recorded. Ensure that products that are released and distributed to market conform to registered and regulatory requirements and are manufactured to cGMP.

  Key Responsibilities:

  • To liaise with other functions as appropriate in dealing with incidents affecting product quality or compliance, ensuring that deviations from GMP, specifications or company standards are fully recorded, remediated and investigated.
  • To include the review/endorsement of CAPA proposals and to provide Quality approval of GMP procedures and documents.
  • Participate in management monitoring of Quality processes and support wider value stream management monitoring activities.
  • Provide necessary support in the investigation of customer or vendor complaints.
  • Identify potential quality issues within manufacturing/packing/warehouse operations or other non-manufacturing areas as appropriate (via inspection, GEMBA and process confirmation).
  • Ensure manufacturing, packaging, Warehouse and wider support process changes are controlled appropriately and the impacts adequately assessed and monitored.
  • Ensuring that product released/shipped conforms to the required quality standards.
  • Provide quality oversight of facilities, equipment and personnel.
  • Support Distribution Risk Assessments (if applicable).
  • Coach staff in setting and maintaining appropriate quality and compliance standards and liaise with supported functions in providing quality guidance through TAP process, Gembas and quality meetings.

  
  As part of the quality assurance team, you will actively promote team working and effective communication across the Ware site and across GSK’s wider Quality functions (at other sites).

  Operational Quality – Please note that this role requires the successful applicant to be based/work in the GMP area for the site.

  Shift: Please note that this role is aligned to the DANFL (24/5) shift-pattern. Shifts are 12-hour shifts and operate on Days (circa 7:00 to 19:00) and Nights (circa 19:00 to 7:00) working on a 3 (day or night) shift rotation.

  About You:

  As this role is multi-faceted and includes liaising with a wide variety of on-site production and operations teams, you will be a self-motivated individual who has strong experience of working in quality and/or manufacturing at a complex manufacturing site. You will be resilient and calm under pressure, with strong people skills and a proven ability to influence people to achieve objectives and drive performance. You will have a strong continuous improvement mindset. Effective written and verbal communication and excellent interpersonal skills, as well as the ability to organise and prioritise workload are considered essential skills.

  About Ware Manufacturing Site:

  Medicines at Ware are presented as either Respiratory devices or in Oral Solid Dose form. The site holds a unique position in our network as the only site responsible for launching the company’s pipeline of new medicines in these dose forms, many of which are life saving medicines. A series of investments in new state-of-the-art equipment are being made that will support the delivery of a record number of new products.

  CLOSING DATE for applications: Monday 8th of January 2024 (COB).

  Basic Qualifications:

  • BSc in Scientific, Technical or Engineering discipline (or equivalent experience, ideally gained working in a Pharmaceutical Manufacturing Facility or similar highly regulated industry).
  • Knowledge of current Good Manufacturing Practice requirements.
  • Knowledge and application of the principle of the Quality Management Systems (QMS).

  Why Us?

  GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

  Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

  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 neurodiversity, 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.

  Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Ukdiversity.recruitment@gsk.com or 0808 234 4391.

  Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive .

  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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• About the company

  GlaxoSmithKline plc is a British multinational pharmaceutical company headquartered in Brentford, England.

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