Job Purpose :
Due to increased regulatory focus on issues that emanate from regulated GxP computerized systems that impact product quality and patient safety.
The e-Compliance specialist shall support the compliant implementation and maintenance of GxP computerized systems and data within business unit.
e-Compliance Specialist shall ensure that GxP computerized 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 Lead with process improvements and provide subject matter expertise and guidance.
Oversight and Governance of Site Auditing System (Internal Business monitoring L2 and Management Monitoring L1)
Manage the site Compliance activities to ensure Quality of site and third-party products is in compliance with the GSK Quality Standards and all relevant regulatory and legislative requirements.
Educational Requirement :
Pharm-D or B-Pharm, Bachelor of Science preferably in Computer Science, IT, Engineering, Automation, Engineering or related technical field or significant professional experience
Profound knowledge in computerized 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
Experience Requirement :
At least 5 years’ experience in the pharmaceutical industry with 3 years+ experience in either Quality Assurance, Quality Management, IT , e-Compliance or equivalent
Key Responsibilities :
As Quality and Compliance Authority within site, act as a single point of contact (SPOC) for the procurement of computerized 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 computerized 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 computerized 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 computerized systems is documented and independently reviewed and approved
Assist with global and site compliance initiatives (assessment, program, reviews, etc.)
As Subject Matter Expert (SME) for computer systems validation within site : shall support the e-Compliance with the creation and review of quality related procedures and material which impact their business unitprovide 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 site IRT Leader; providing support for follow up and or remediation actions related to regulatory inspections
Act as Global e-Compliance support
To support Inspection Readiness within region for Global Systems supported by IT.
In the event of an audit by a Health Authority within region, e-Compliance Specialist will be the global e-Compliance SPOC and part of the Inspection Management Team
Oversight and Governance of Site Auditing System (Independent Business monitoring L2 and Management Monitoring L1)
Govern and maintain Site Internal Audit System by maintaining Audit Universe and Schedule and ensure adherence to Schedule.
Govern and maintain Site Self Inspection System and provide SME support to all GxP functions for Universe and schedule creation and adherence.
Assess Compliance to standards and identify gaps, determine if the compliant practices are implemented and determine if the ways of working are effective and suitable to meet the auditee 's objectives
Ensure adequate preparation of Health Authority inspections and audits from third parties and GCA. Lead the management of these inspections / audits and their follow-up.
Ensure that corrective and preventive actions (CAPAs) are tracked and implemented as committed and ensure timely escalation of issues related to CAPAs.
Regularly report the status of CAPAs.
Support in Regulatory Inspection Management and Correspondence against Regulatory letters.
Create new Site KPIs, manage, track and report all Site KPIs (local and / or Global).
Comply and ensure compliance to GMP (Good Manufacturing Practices), Quality and other related policies, guidelines and requirements as applicable by law and GSK Corporate Guidelines.
Comply and ensure compliance to Environment, Health and Safety policies, guidelines and requirements as applicable by law and GSK Corporate Guidelines.
Any other responsibility assigned from time to time as per business requirements.
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