Product and Technology Lead

About Haleon:
Hello. We're Haleon. A new world-leading consumer company. Shaped by all of us. Together, we're improving everyday health for millions 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 building together. In an environment that we're co-creating. And a culture that's uniquely ours. Care to join us. It isn't a question.

Job Purpose:
Owns Product Lifecycle Management (PLM) covering product and process development as a part of technical risk assessments (TRA), process qualification (Stage2a &2b) and continued process verification to ensure that the process remain in a state of control during routine production in order to comply with cGMP requirements and regulatory agencies. Develops, implements and manages Site process validation, primary packaging validation, cleaning validation and revalidation strategies.

Key Responsibilities
:

Validation Master Plan

• Establishing and maintaining the validation schedule rendering to site validation master plan for process, cleaning and packaging validation in partnership with Quality, Engineering and all other function to continue common approach and translate that for the site
• Establish and manage the respective validation plans by aligning, coordinating and supervising the prioritization of activities against the business needs. Reviews risk assessments for validation.
• Maintain all validation activities in an inspection ready status ahead of any internal or external audits to ensure successful inspections e.g. no critical observations related to validation activities

Validation activities:

• Manage team in partnership with Validation lead to ensure that all Site process, cleaning and primary packaging validation activities are performed and are in line with the current and cGMP requirements, handling any deviations associated to these activities including oversight of pre-validation and validation resulting from technical changes.
• Review and/or author routine validation or re-validation protocols & reports, reviews batch manufacturing and packaging records (BMRs/BPRs), associated change controls and supports the execution at the shop floor.
• Participate in transfers and launches, liaise with technical development for new products and align on the product validation approach. Also, contribute to provide experimental data obtained during the validation activities, which will be used to prepare the related registration documentation.
• Participate/Support in improvement, investigations and remediation of products by being a senior advisor in case of difficult validation challenges at Site.

Product Ownership:

• Manage and Liaise with Global Product Owner/lead at global level and locally with functions with focus to ensure and improve product process capability, to keep up to date the knowledge of process and to maintain the product in constant state of validation
• Manage and Lead Technical Risk Assessment (TRA) as L2 Mentor and accredit others for L1. By building, coaching & delivering Technical capability related to TRA and statistics across Product Owner/ Technologists.
• Lead Trend review meeting with cross functional team and statistical analysis of products to identify opportunities of improvement and deepen & broaden process understanding and knowledge and Detect issues in Process capability, such as systematic quality effects.
• Track and ensure completeness of all actions identified in PLM improvement plan for its on-time delivery by partnership with QA and manage team so that for tracking of CPV parameters from production, QC, control systems, etc. and all critical variables as appropriate for all the product(s) (Critical Process Parameters CPP, In Process Control IPC parameters, Quality Attributes, Characteristics of raw materials. etc) using statistical analysis and conducting regular product specific data trending.
• Actively participate as a site representative for all product(s) in the relevant committee along with assigned product owner (e.g. Product Technical Review Team-PTRT), where the improvements on weak point products are planned, prioritized and monitored.
• Provide expert knowledge and technical support of product to new product introduction (NPI) / launch at site and also to Validation team on time
• Comply and ensure compliance to GMP (Good Manufacturing Practices), Quality and other related policies, guidelines and requirements as applicable by law and Corporate Guidelines.
• Comply and ensure compliance to Environment, Health and Safety policies, guidelines and requirements as applicable by law and Corporate Guidelines.
• Any other responsibility assigned from time to time as per business requirements.

Skills and Competencies:

• BSc. in Pharmacy/Engineering, Pharmaceutical Technology, Chemistry or equivalent scientific degree.
• Minimum of 5 years of demonstrated experience in a regulated technical role, with strong experience in TRA, Validations including cleaning validation. Demonstrated experience in the FMCG or Pharmaceutical industry leading the technical aspects of new product introductions, technology transfers, technical risk assessments, product control strategies, validation, and change control

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

Why Join Us?
The future of everyday health is changing. And we're the people changing it. In front of us is an incredible opportunity to go beyond what any of us have done before. And make everyday health more achievable, more inclusive and more sustainable. For more and more people.

So join us, as we build one of the world's leading consumer companies. Join us to innovate our category-leading brands. To better understand people's everyday health needs. To tackle the biggest barriers that stand in their way. To change individual and societal behavior.

In our efforts to further tackle barriers that may be standing in our way, we have implemented what we call a Hybrid Working model, known as Home office. Home office in the country of employment is permitted for all employees whose position allows it. The employee and the manager agree on the circumstances in which working from the office is required and in which the employee can work remotely or specific local arrangements. This helps us with ensuring that we maintain a healthy work-life balance, and give our best to our people.

Join us to work with colleagues who share your restless energy. To explore your interests. To stretch yourself to do the best work of your career. And join us, as together we build a working experience that encourages us all to lead happier, healthier, more productive lives.

The way we see it, every day is an opportunity for better. And we're going all in to realize it.

Care to join us. Find out what life at Haleon is really like

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.

Accommodation Requests

If you require a reasonable accommodation or other assistance to apply for a job at Haleon at any stage of the application process, please let your recruiter know by providing them with a description of specific accommodations you are requesting. We'll provide all reasonable accommodations to support you throughout the recruitment process and treat all information you provide us in confidence.