Site Data Integrity & E-Compliance Lead

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. It isn’t a question.

With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we’re uniquely placed to do this and to grow a strong, successful business.

This is an exciting time to join us and help shape the future. It’s an opportunity to be part of something special.

In this role.

You will Lead the implementation of the data integrity strategy at the Site, ensure compliance with global and local regulatory requirements at the system level Documentation and Electronic Systems that generate and manage GxP processes.

Key responsibilities

• Ensure the implementation of the corporate requirements of the 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.

• Generate communication and work plans with the different areas 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.

• Coordinate with cross functional team in assessing GxP systems (IT management systems, analytical and productive) with respect to impact on Product Quality & Patent Safety.

• Communicate team for data controls required to prevent or detect existing data vulnerabilities in systems (where required).

• Perform routine inspection readiness Gemba and DI Gemba to improve Compliance Culture towards applicable policy and procedures ensuring Good Documentation/data practices meeting data integrity expectations across data lifecycle.

• Perform and Lead Management Monitoring and Internal Business Monitoring for compliance check and to identify good practices and areas of improvements in existing way of working and ensure CAPA/action plan and tracking in Veeva for timely completion as per approved schedule.

• Establish and lead an internal site network of DI champions and actively participate in the multisite DI community of practice, share best practices with other sites in the network and communicate best practices from other sites internally so that risks could mitigate reasonability.

• As role of E-Compliance Lead, ensuring compliance with computerized system policies and regulations.

• Provide assistance to site team as “Admin” role on assigned QC Equipment/ Systems and validated GxP spreadsheets across site.

• Ensure that the Site has a Comprehensive "Site Validation Master Plan" and it is properly executed according to approved schedule of activities.

• Oversight all Validation activities at site including process validation, cleaning validation and equipment qualification according to Site Validation Master Plan.

• Review all documents related to process validation, cleaning validation and equipment qualification according to Site Validation Master Plan

• Follow quality system and procedures for PPR in compliance with Haleon Quality Systems requirements.

• Participate in Global & BU QMS CoPs to present status of QMS for Jamshoro site.

• Assist in robust investigation of Data Integrity related incidents as per company procedures, leveraging real root causes or gaps for further improvement opportunities in exiting processes and practices through identifying effective and sustainable CAPAs. Identify roles and responsibilities for execution of holistic mitigation plans necessary to meet data integrity standards.

• Establish and lead an internal site network of DI champions and actively participate in the

Qualifications and skills

• Pharm D/ MSc. Chemistry/ Microbiology/ BE (Any field) or Computer Science.

Preferred:

• Minimum 3-5 years’ experience on the same capacity especially in the Pharma or related Industry, can be mixed with FMCG.

Other Skills/Qualifications:

• QMS implementation

• Data Integrity strong understanding and experience

• Electronics Systems audit trials

Please save a copy of the job description, as this may be helpful to refer to once the advert closes.

Diversity, Equity and Inclusion

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone.

We’re striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Care to join us. Find out what life at Haleon is really like www.haleon.com/careers/

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure Haleon’s compliance to all federal and state US Transparency requirements.