Job Description

Site Name: Hyderabad Connaissance Park
Posted Date: Feb 20 2023
Hello. We\xe2\x80\x99re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we\xe2\x80\x99re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands \xe2\x80\x93 including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum \xe2\x80\x93 through a unique combination of deep human understanding and trusted science. What\xe2\x80\x99s more, we\xe2\x80\x99re achieving it in a company that we\xe2\x80\x99re in control of. In an environment that we\xe2\x80\x99re co-creating. And a culture that\xe2\x80\x99s uniquely ours. Care to join us. It isn\xe2\x80\x99t a question. The Haleon Contract Manufacturing Organization (CMO) is a vital component of the GMS supply network, currently supplying more than 45% of our global product portfolio to the market and underpinning a significant share of the total CH sales revenue. Multiple dose forms are sourced from the CMO network, including oral solid dose (tablets, hard, and soft capsules), powders, oral liquids, creams, ointments, nutritionals, respiratory, and medical devices. The geographic reach, varying ways of working, and dose form complexity, requires strong Technical talent to ensure that Haleon standards are adhered to in our CMO environment. Due to a significant investment in technical resources for CMO, we\xe2\x80\x99re recruiting for a Product Owner to support the External Manufacturing sites located in the India Supply Chain region for Haleon. A major focus of this role will be to support the Panadol Transformation Programme and global supply from our contract manufacturing sites and new sites in India and in wider Asia region. This product owner will manage Technical activities across multiple dose forms and contract manufacturing companies to support continuous improvement and process robustness to ensure consistent supply and to lead product transfers and new product introductions (NPIs) in partnership with QA, product development, commercial and other teams in Haleon. Responsibilities:

• Recognised as the principal point of contact for all aspects of current and previous knowledge on the product(s), performance and end to end process, including critical quality attributes (CQAs) and critical process parameters (CPPs). Accountable at site level for maintaining this knowledge and sharing on site and globally as appropriate.
• Responsible for ensuring all aspects of Product Quality Lifecycle Management are in place and actively maintained for the product(s): Technical Risk Assessment, Product Control Strategy (and translation to standard work as batch manufacturing instructions as per the principles of GPS), Continued Process Verification and Process Robustness Assessment. Ensures risks are identified and escalated as appropriate and mitigation plans are in place and agreed within appropriate quality systems e.g. CAPAs or governance boards
• Ensures QbD principles are applied and a robust and well understood process and product control strategy are transferred during technical transfer, full scale development and commercialisation of new products from R&D, and subsequent transfers to other sites.
• Maintains accountability for the product throughout its lifecycle, influencing the manufacturing process, analytical process, pack, device, and associated specifications including technical input to the lifecycle validation approach for the product.
• Responsible for assessing the product quality impact of any change (AL 1/2/3) that can impact CQAs/CPPs via review and update of TRA and PCS, e.g. assessment of the impact of AL2/AL3 primary changes impacting API material properties (primary product owner), assessment of impact of API/excipient changes on the dose form (secondary product owner), via the Material Risk Assessment process (MRA), PLC/recipe control system changes, valve design changes etc
• Provides leadership and establishes key relationships within site across Operations, Technical, Quality and Engineering for the product(s) for which he/she is accountable, and above site with other Product Owners and R&D. May provide leadership to others, such as Technologist roles at site, and maintains a matrix reporting relationship to the central and regional Technical groups.
• Provides technical input to regulatory submissions for first file, post-approval submissions, annual reports, Periodic Product Reviews, and internal and external audits.
• Provides technical leadership and input into root cause analyses to support the investigation and resolution of product complaints and deviations, in conjunction with QA and operations.
• Leads Product Technical Review Team (PTRT) if Product Owner for drug product Identifies, develops and trains successors for the role, and coaches others in his/her area of expertise, ensuring other functions (e.g. operations) have sufficient product knowledge and understanding to execute their roles.
• Being the technical single point of contact in cross-functional teams consisting of Quality, Supply, procurement, and Finance.
• Actively participate in regular CMO leadership meetings to drive business and Quality performance goals in the network

Requirements:

• At least 5 years of experience in the OTC, pharmaceutical, or FMCG manufacturing/technical environment
• Hands-on experience working with oral solid dose OTC or pharmaceutical products and manufacturing operations, including granulation, compression, and coating operations.
• Experience working with external manufacturing companies, suppliers, or other partner organizations
• Experience in culturally and geographically diverse environment with ability to work across multiple, complex interfaces preferable
• Demonstrated problem solving capability and ability to communicate, negotiate with and influence effectively all levels of management in the internal and external environment
• A thorough appreciation of quality assurance, global quality procedures, validation principles and regulatory requirements.
• Master\xe2\x80\x99s degree or equivalent experience in Scientific, Technical or Engineering Demonstrated experience in the Pharmaceutical or FMCG industry in leading the Technical aspects of the Product Lifecycle including Technology Transfers, Technical Risk Assessments, Product Control Strategies, Process Capability/Robustness, QbD. validation and change control.
• Detailed knowledge of relevant dosage form including unit operation understanding, functionality and criticality of formulation materials and their transformations (e.g. powder technology, colloid science, crystallisation, isolation, drying and particle size reduction), plant equipment and analytical testing.
• Awareness of device/packaging processes.
• Level 1 Facilitator for TRAs (\'Proficient\' level as defined by the TRA competency framework) Capability to develop basic materials and formulation science input into RCAs (criticality and functionality of materials) and TRAs (particle science and formulation expertise).
• Knowledge of regulatory environment, particularly in markets where product is commercialised. Track record of improving products, processes and trouble-shooting, execution of technical activities including trials and validation activities
• Experienced in technology transfer, with an understanding of the product development process
• Able to evaluate potential innovative technology areas relevant to product
• Thorough knowledge of GMP and EHS requirements
• Demonstrated in-depth knowledge of Quality by Design and risk management approaches
• Able to assess/interpret statistical data e.g. process capability, control charts, DOE, MSA Demonstrates ability to contribute to and effectively influence matrix teams, colleagues in other functions and senior stakeholders
• Demonstrated ability to mentor operational staff and support functions

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\xe2\x80\x99re 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\xe2\x80\x99s compliance to all federal and state US Transparency requirements.