Computer Quality Consultant
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GlaxoSmithKline (GSK) is one of the world's leading research-based pharmaceutical and consumer healthcare companies and is committed to improve the quality of human life by enabling people to do more, feel better and live longer.
In Malaysia, GSK has established a strong presence for over 50 years and is home to our operations in the area of pharmaceuticals, consumer healthcare, manufacturing, and Business Services Centre. GSK employs over 1000 staff in Malaysia.
GSK is an exciting, rewarding and dynamic place to work. We thrive to be different from the conventional corporate ways of working. We pride ourselves on exemplary leadership and sense of community, and we offer a great platform for your personal and career development.
GSK Business Service Centre
The Business Service Centre, Kuala Lumpur is GSK's first global hub in Asia and will play a key role in GSK's Core Business Services consolidating the organisation's global and regional service delivery in IT, Finance, Employee Services, Indirect Procurement and Worldwide Real Estate and Facilities into an integrated shared service network.
This role exists to ensure the quality of strategic computer systems used in the manufacture of pharmaceutical and consumer healthcare products. This role is critical to the successful development, deployment and maintenance of systems used globally across GSK manufacturing and impacting a wide range of products.
This role will manage quality of strategic computer systems such that they are developed, delivered, maintained and validated in accordance with company and regulatory requirements.
- Planning and managing quality aspects of high cost, complex, strategic systems using risk based approaches to ensure systems are fit for purpose, that significant risks are identified and mitigated, and that the approach and rigor applied is in proportion to the risks the systems present to regulated business processes, e.g., agreeing the risk based testing approach.
- Preparation and approval of documentation, fulfilling the Quality Assurance role, in accordance with the relevant processes (e.g. Quality Management System). Ensuring the documentation is created to the right standard and is aligned with the Standard Operating Procedures for each phase of the development lifecycle.
- Interaction with IT, software suppliers, and outsource companies to influence activities that may impact the quality of computer systems.
- Problem resolution/avoidance – this typically involves ongoing interaction with IT Managers/Directors, site Managers and senior management of suppliers.
- QA Support of the deployment and maintenance of multiple (3-7) global projects including responsibility for the developing solutions that maintain compliance whilst achieving schedule and budget.
- Managing the collection of data for the assigned KPIs and Service Level Agreements
- Providing oversight and training to internal and external suppliers, e.g., IT teams and globally sourced providers.
- Completion of Periodic Compliance Review activities to ensure ongoing compliance of the systems in the maintenance phase. Negotiating the required corrective actions.
- Ability to work under minimal supervision; assess priorities and work well under pressure in a fast paced environment.
- Previous involvement within the Pharmaceutical environment (GMP and/or 21 CFR part 11)
Strong verbal and written communication skills.
Please apply online.
You may apply for this position online by selecting the Apply now button.
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