Your Responsibilities :
As the Quality and Compliance Authority within their respective business unit they shall
act as a single point of contact (SPOC) for 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 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 eCompliance and Data Integrity 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
Basic qualifications :
Bachelor of Science preferably in Computer Science, IT, Chemical Engineering, Automation, Engineering Pharmacy, Biology, or related technical field or significant professional experience
Profound 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 validation and maintenance of Process and Distributed Control Systems, Laboratory and Clinical Systems and or Software
Good understanding of the key expectations of the guideline documents supplied by FDA & MHRA, PIC / S and ISPE(GAMP).
Knowledge of :
Software Supplier Audits
Software Development Lifecycle
Change Control, Deviation and CAPA Management
Preferred qualifications :
At least 5 years’ experience in the pharmaceutical industry with 3 years+ experience in either Quality Assurance, Quality Management, IT Compliance or equivalent.
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
Why GSK? :
Our Consumer Healthcare business develops and markets products in Wellness, Oral health, Nutrition and Skin health categories.
Our seven global power brands Otrivin, Panadol, parodontax, Poligrip, Sensodyne, Theraflu and Voltaren, include some of the most trusted
and best-selling brands in the world.