Validation Consultant: Compliance, Data
Due to the increase in regulatory focus on electronic data integrity issues that emanate from regulated GxP computerised systems that impact product quality and patient safety the eCompliance & Digital Quality Consultant shall support the compliant implementation and maintenance of GxP computerised systems and data within their respective business unit.
They shall ensure that GxP computerised systems operate within the framework of applicable health authority regulations (e.g.: 21 CFR Part 11 & EU Annex 11) and that global policies and procedures are in place that align with regulatory expectations and best practice.
In addition, they shall support the Global e-Compliance & Digital Quality Lead with process improvements and provide subject matter expertise and guidance.
- 5+ years of knowledge in computerised systems validation (CSV) and electronic data which impact cGMPs, GLP, GCP, GDP, EU Annex 11, Annex 15 and Code of Federal Regulations and in Data Integrity within CSV
- Familiar with the software development lifecycle (SDLC), Software Engineering standards and the validation and maintenance of GxP Computerised Systems. For example, Process and Distributed Control Systems, Enterprise Systems deployed and supported by IT, Laboratory and Clinical Systems
- Good understanding of the key expectations of the guideline documents supplied by FDA & MHRA, PIC/S and ISPE(GAMP).
- Knowledge of:
- Project Management
- Software Supplier Audits
- Software Development Lifecycle
- Change Control, Deviation and CAPA Management
- Strong communication and negotiation skills (oral and written) and can negotiate and influence ‘best practice’ through positive communication with system owners, third party support organizations such as Information Technology, Off Shore Support and complementary workers
- Demonstrate a proficient and thorough knowledge of computer system validation (CSV) as defined by health authorities (FDA, EMEA, ICH), industry groups and the GSK QMS
- Experience in international and multidisciplinary environments
- Demonstrates attention to detail and organizational skills
- Strong interpersonal skills
- Willingness to travel
- Results driven with a strong customer and quality focus
- Ability to make decisions, evaluate risks and define and execute action plans
- Ability to propose innovative solutions to solve problems
- Fluent English required (written and spoken). Additional languages are a plus
- Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role
- As the Quality and Compliance Authority within their respective business unit they shall
- act as a single point of contact (SPOC) providing quality governance and support during the procurement of computerised systems providing subject matter review and approval of key validation documents for the full lifecycle from implementation through to retirement for their business unit
- follow up on compliance activities which impact the validated status of computerised systems within their business unit
- provide the necessary subject matter support for audit types in their business unit. Audits may include but not be limited to regulatory, supplier and internal assessments that impact the computerised systems
- maintain customer service relations and develop and sustain professional relationships that reflect commitment to GSK shared values. Foster communication across the CH e-Compliance team
- ensure that the justification for validating computerised systems is documented and independently reviewed and approved
- assist with global and site compliance and data integrity initiatives (assessment, programme, reviews, etc.)
As Subject Matter Expert (SME) for computer systems validation within their respective business unit they
- shall support the Global e-Compliance & Digital Quality Lead with the creation and review of quality related procedures and material which impact their business unit
- provide subject matter support to System Owners, Service Providers and vendors within their business unit and maintain the System Register
- work independently by determining and pursuing courses of action to obtain desired functional and business objectives
- Support Inspection Readiness preparation with close collaboration with Audit Co-ordinator(s); providing support for follow up and or remediation actions related to regulatory inspections
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