Job purpose :
The Data Integrity Leader within the CH Supply Chain Business Unit will be responsible for leading the implementation of the data integrity strategy at the site.
Ensuring compliance with global and local regulatory requirements for both paper-based and electronic systems that generate and manage data across all GxP categories.
Key responsabilities :
Ensure the implementation of the corporate requirements of the Quality Management System by :
1.(Quality Management System) and regulatory requirements in relation to data integrity, including the development of indicators that monitor the process and performance at the Site level.
2. Generate communication and work plans with the different areas in order to ensure the Prevention and Detection of Data Integrity events, for example, through Implementation of Training Matrices, Communicate Good Data Integrity Practices and the implementation of related work tools.
3. Coordinate the evaluation of new and existing systems (IT management systems, analytical and productive) with potential impact on product quality and generate mitigation plans for meet the requirements.
4. Identify roles and responsibilities for the review, approval and execution of mitigation plans necessary to meet data integrity standards.
5. Ensure the progress and compliance of the mitigation plans for electronic systems and documentation.
6. Assist with the development of or carry out Gemba’s / Process Confirmations to ensure that the procedures associated with general guidelines for systems and documentation are in place.
7. Participate in the gap analysis of the policies associated with Data Integrity ensuring local SOPs are aligned to corporate requirements.
8. Provide support in the event of internal, external and regulatory audits. Provide support in capability building of site key SMEs regarding DI requirements and expertise.
9. Performing quarterly updates to the data integrity elements of the quality risk model.Ensuring the site is maintaining a high level of control and mitigating any risk elements when appropriate.
10. Assist with Data Integrity related investigations and incidents.
11. Ensure Data Integrity related CAPA’s are effective and sustainable.
Basic Qualifications :
Chemistry technician CFC or equivalent With knowledge equivalent Analytical Chemistry Knowledge of technique used in QC chemistry laboratory (LC, GC, TLC )
Preferred Qualifications :
Minimum 6 years’ experience in a Pharmaceutical EnvironmentProven process understanding (Pharma, GMP, investigation and method development)Continuous improvement experience (Lean, 5S, Problem Solving).
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.
As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities :
Operating at pace and agile decision-making using evidence and applying judgement to balance pace, rigour and risk.Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
Continuously looking for opportunities to learn, build skills and share learning.Sustaining energy and well-being.Building strong relationships and collaboration, honest and open conversations.
Budgeting and cost-consciousness.
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