Qms Champion and Data Integrity Lead
vor 1 Monat
Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands - including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum - through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us.
This is an exciting time to join us and help shape the future. It’s an opportunity to be part of something special.
About the role
The purpose of this role is to:
- be the SPOC with the Global Quality Organization to ensure that the Haleon Quality System (Quality Management System) is implemented in timely manner and used correctly on site. The role will involve working with all grades and departments on site.
- be the Risk Management Process Owner to ensure that process to identify, document and escalate risk is in place and in use as per Global process.
- ensure that KPIs are collected, analyzed and escalated to Site Quality Council (SQC) on time
- ensure process of Change Control, Deviation, CAPA, Laboratory Investigation and compliance are in place and in use on site, and aligned with HQS
- ensure Quality Alert / Quality Bulletin (QA/QB) are assessed and all CAPAs associated managed at site level are correctly defined and implemented in timely manner
- calculate and report Nyon Site QA operational KPIs to Site and corporate level.
- be Data Integrity Champion 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 Responsibilities
Data integrity Champion:
- Lead 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.
- 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.
- Develop DI Quality plan that summarizes all the action related to DI Journey on site.
- 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.
- 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.
- Coordinate the evaluation of new and existing systems in close collaboration with CSV/QA teams(IT management systems, analytical and productive) with potential impact on product quality and generate mitigation plans for meet the requirements.
- Ensure the progress and compliance of the mitigation plans for electronic systems and documentation.
- Assist with Data Integrity related investigations and incidents. Identify roles and responsibilities for the review, approval and execution of mitigation plans necessary to meet data integrity standards. Ensure Data Integrity related CAPA’s are effective and sustainable.
- 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.
- Share best practices with other sites in the network. Communicate best practices from other sites internally so that risks can be mitigated. Actively participate in the appropriate Data Integrity Site Leader Community of Practice.
2. Haleon Quality System Champion:
- Ensure that the site is operating with the full intent of the Haleon Quality System.
- Transfer to the SMEs and stakeholders all the relevant communication from the QMS Global Quality Organization.
- Monitor and report the overall effectiveness of HQS implementation.
- Ensure that the site is implementing updates in-line with the intent of the HQS.
- Be the Subject Matter Expert for the HQS on site and during internal audit, customer audit and health authority inspections.
- Support the permanent inspection readiness (PIR) program for all activities related to the HQS
- Be part of the HQS Community of Practice to share good practices, align on regional strategy if applicable, benchmark with other sites.
3. Risk Management Process Owner (RMPO):
- Ensure deployment of Risk Process on site.
- Lead local process to escalate risk to Site RMCB and be the representative for EU RMCB.
- Be the first level of support with the Risk Management System to support all departments. Be the Subject Matter Expert for the
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