Ware (Hybrid Working)
Who Are We - GSK?
We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. GlaxoSmithKline plc was formed in 2000 as a result of a merger between Glaxo Wellcome plc and SmithKline Beecham plc, although our history can be traced back more than 300 years to London’s Plough Court Pharmacy in the 1700s.
Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. Our strategy is to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our three global businesses, scientific and technical know-how and talented people. Our values and expectations are at the heart of everything we do and form an important part of our culture:
• Our values are Patient focus, Transparency, Respect, Integrity
• Our expectations are Courage, Accountability, Development, Teamwork
As a Validation QA Officer role in Small Molecule Quality Assurance (SMQA), Infrastructure and Validation team, you will perform the quality assurance activities and quality oversight of the Validation and GMP facilities management activities performed within Pharma R&D across the sites globally.
In this role you will be key in the following areas…
• Providing review and approval of validation lifecycle documents from a variety of QMS with the company. Provide meaningful comments to ensure compliance with regulatory expectations/requirements.
• Provide quality oversight of internal business groups and external services partners inclusive of the following quality processes:
• Change control
• Deviation investigation
• Audit Support
• Vendor Complaints
• Quality Alerts
• Support internal and external audits/assessments.
• May lead a project, quality program or team activities.
• Identify business, compliance or reputational risks associated with job responsibilities and communicate these upward along with suggestions for risk management solutions.
• Provide advice and consultancy to GSK project teams, internal business groups and external partners to reduce regulatory risk to GSK.
• May represent QA group as a primary business contact for specific areas.
• Build and maintain effective business relationships within internal business units and service partners.