GlaxoSmithKline Quality and Validation Leader in United States
Quality and Validation Leader
Open date:Jul 16, 2018 1:08 PM
GSK House, Brentford,
Required degrees:Not Indicated
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Your Responsibilities:Are you a Quality / Validation Specialist seeking your next exciting opportunity where you can directly impact in helping us enable our customers to Do More, Feel Better and Live Longer?
We’re looking for a Quality and/or Validation practitioner to join the Pharma Quality ERP team to support the implementation and on-going maintenance of our strategic computerised systems.
You’ll use your quality and validation expertise to ensure the automation of business processes associated with pharmaceutical manufacture and distribution meet patients’ needs and regulators expectations.
You’ll work in projects associated with our Enterprise Resources Planning (ERP) and Distribution systems that is a business way of working based upon the SAP R/3 software application that manages data and workflows across our supply chain. In addition, you will also be responsible for:
• Preparation and approval of validation documentation or management of the process (fulfilling the Quality Assurance role) in accordance with the relevant processes (e.g. Quality Management System)
• Monitoring project and/or support activities to ensure systems are fit for purpose, that significant risks are identified and mitigated, and that the approach and rigor of validation is in proportion to the risks the systems present to regulated business processes
• Providing and/or facilitating quality assurance oversight for the automation of business process associated with pharmaceutical manufacture and distribution
• Project problem identification/resolution/avoidance; typically involving ongoing interaction with management teams within IT functions, site and local operating company Quality organisations, and Third Party suppliers/service providers
• Participating in the deployment, maintenance and inspection support of multiple (3-7) global projects including responsibility for the developing solutions that maintain compliance and keep validation on schedule and on budget
• Ensuring issues/risks are identified, mitigated and/or escalated for items that could adversely impact quality compliance associated with projects/systems
• Provision of performance measures to drive performance and continuous improvement
Your broad experience within pharmaceutical industry will include quality assurance / compliance and validation. The successful candidate will be self-motivated, enjoy equally working within a team and autonomously, thrive on working in a diverse, high volume environment and be highly organised.
You'll be supported by a diverse global team and encouraged to realise your full potential through a personalised development plan.
Applicants must demonstrate in their application how they meet the above criteria in order to be successful for interview selection.
CLOSING DATE for applications: Friday 27th July 2018 (COB).
Please Note: This role is based at GSK House, Brentford however there is flexibility to be based at other sites within our UK network.
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.
Basic qualifications:• BSc in Scientific, Engineering, IT discipline or similar / equivalent experience
• Understanding of pharmaceutical manufacturing and distribution regulations, guidelines, principles and expectations
• Understanding of validation lifecycle
• Demonstrated ability to interpret and apply company guidelines, principles and expectations such that systems are validated in proportion to the risk they present to patient safety and product quality
• Demonstrated ability to handle multiple priorities and complete work within agreed timescales e.g. key QA role deliverables
• Experience as an effective communicator with ability to collaborate and form strong partnerships within teams and diverse stakeholders/customers that result in "win-win" outcomes to achieve business goals and objectives
Preferred qualifications:• Broad experience in independently providing validation, deployment, change management, and inspection support of large, complex, computerised systems
• Technical knowledge to support quality and validation decision making for GxP analytical, manufacturing, distribution and IT computerized systems
• Demonstrated ability to successfully manage support to regulatory inspections including specific queries of computer systems validation/compliance activities and documentation
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
You may apply for this position online by selecting the Apply now button.
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