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The Senior Scientist - Equipment Validationprovides validation services for computerized systems in use within Medicine Development & Supply (MDS) in accordance with GMP requirements, MDS and Corporate policies. The Senior Scientist - Equipment Validationwill e nsure that computerized laboratory analytical equipment / systems used to support regulatory submissions and develop, test and / or manufacture product within MDS are qualified and / or validated and maintained in a validated state in accordance with the relevant regulations and corporate policies and standards in order to ensure patient safety, product quality and regulated data integrity.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
Why you? Basic Qualifications:
- Contribute to project teams to ensure that MDS's information resources and computerized systems are developed, implemented, and managed in accordance with corporate quality standards and regulatory requirements.
- To maintain an overall knowledge of MDS functions to ensure that validation / compliance needs can be easily identified, recommendations made, and implemented to ensure compliance within acceptable agreed business risks without compromising quality.
- To maintain a high degree of knowledge regarding relevant regulations, procedures, and quality standards.
- To assess and manage risk as it relates to computer validation and analytical equipment qualification procedures.
- To ensure that all MDS computerized analytical systems validation activities, whether carried out by MDS staff or internal / external suppliers, are performed to required standards.
- To prepare validation documentation to agreed standards, including contribution to and reviews of documents authored by other groups (e.g. R&D IT).
- Serve as a contact for the Laboratory Instrumentation Services group or local equivalent as it relates to analytical equipment qualification
- To provide regular and appropriate updates and status reports to management
- Provide computer and analytical equipment validation advice and training to the product development staff
- Lead the progression of projects through the department within designated timescales.
- Conducts other defined packages of work as directed by a senior member of staff.
- Able to contribute innovative approaches to achieve project goals
- Makes effective decisions to achieve desired outcomes of immediate work group.
- Anticipates/recognizes potential problems with equipment and/or supplies, and initiates action to solve or prevent problems.
We are looking for professionals with these required skills to achieve our goals:
- Bachelors degree in scientific discipline or computer sciences or 5+ years of computer/science/pharmaceutical industry experience.
- Experienced in understanding and complying with product development processes and relevant regulations (e.g.: GMP, 21 CFR Part 11, MHRA).
- Experience in validating analytical laboratory equipment.
If you have the following characteristics, it would be a plus:
- Experience with enterprise applications and deploying IT systems within a regulated environment (Computer System Lifecycle Management)
- Experience with laboratory equipment such as HPLCs, NMR, XRay
- Team Work - Actively involved in team activities. Works and co-operates with others, sharing information. Has an open, positive, non-competitive stance towards others in the team. Knows and understands team goals.
- Communication - Expresses ideas effectively, adjusting language or terminology to the needs of the recipients. Creates a good impression, commands attention and respect, shows self-confidence. Impactfully conveys ideas and rationale through oral presentations and written communications.
- Customer Focus - Identifies, implements, and continuously improves work processes. Emphasizes the need to deliver quality products and/or services by defining standards and evaluating processes and services against those standards. Anticipates customer needs and continually searches for ways to increase customer satisfaction.
- Influencing, networking and rational persuasion - Focuses on problem rather than person. Presents arguments based on factual information. Ability to weigh up information and come to a decision. Develops and uses personal relationships with a variety of line managers and key stakeholders to achieve goals.
- Concerns for standards - Sets high personal standards as an example. Makes sure that work meets quality standards and takes firm action on sub-standard performance. Explicitly defines the consequences of not meeting standards.
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we're making the most significant changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022:
New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients
- so we deliver what matters better and faster; accountable for impact
- with clear ownership of goals and support to succeed; and where we do the right thing
. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.
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