Job Description

Site Name: Malaysia - Kuala Lumpur
Posted Date: Feb 20 2023
Why Haleon?
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. This is an exciting time to join us and help shape the future. It\xe2\x80\x99s an opportunity to be part of something special. We are currently looking for experienced Product Owner to join our Manufacturing Ulu Kelang office. You will be responsible for product ownership, provide technical leadership for locally or globally manufactured product and /or product families, ensuring technical inputs yield robust manufacturing process and product manufactured meeting requisite product quality attributes at all times. Other Key Responsibilities: Own the product, be the subject matter expert or \xe2\x80\x98go to\xe2\x80\x99 person, provide technical leadership and advice on product or products under product owner\xe2\x80\x99s portfolio.

• Ensure all aspects of PLM- product lifecycle management are in place and are actively maintained.
• Perform Technical Risk Assessment (TRA)for their product(s)
• Maintaining Development / Manufacturing History
• Performing TRAs throughout product lifecycle and ensure that knowledge within TRAs is retained
• Developing key TRA documents including associated output reports
• Define critical process parameters (CPP) and Critical Quality Attributes (CQA), document the Product Control Strategy (PCS) and work with operations management to ensure the PCS is embedded in batch instructions and SOP
• Define the testing strategy during the product development.
• Generating plan,protocol and executing process validation for new products, assess the need for revalidation
• Ensuring continuous process verification (CPV) which includes conducting Real Time Trending including the generation of data trending plan and trending of CQA , ensure trending events are escalated, execute mitigation plans and ensure that events resulting from trending reviews in CPV log are routinely updated
• Ensuring alert limits are generated, recalculated as necessary working with a statistically competent person,documents updated
• Proactively monitors data including stability data, highlight tends and makes recommendations for continuous improvement.

Provides technical leadership in raw material (API -active pharmaceutical ingredients or excipients) source change via

• Providing provisional material purchase specifications for potential suppliers
• Conducting Material Change Assessment (MCA) for material changes at site level by assessing existing process/product capability and material specification, if required material characterisation data to identify potential failure mode and overall level of risk associated with the change. For centrally managed changes where FMEA -failure mode effect analysis and MCA are shared, to review and identify additional risks
• Determine the qualification strategy including stability requirements based on the MCA by coordinating and executing trials, validation and stability as required. Prepare documentation for trial or validation protocols and reports as required.
• Establish and maintain product knowledge expertise, ensuring critical processing knowledge is translated effectively to operational personnel and others as required.

Support reduction in site NRFT, achieving predetermined targets for technical related deviations, through proactively identifying such issues and putting into place appropriate QbD based actions. For deviations and complaints; provide technical leadership so as to effectively and efficiently:

• identify the root cause;
• institute actions that will remediate the effected stock (as necessary) and permit its release;
• provide appropriate mitigation as necessary for ongoing supply; and
• institute steps to prevent a recurrence of the issue. For change controls; provide sound technical advice in order that an appropriate risk based process to implement and its disposition can be assigned.

In a New Product Introduction (NPI), take accountability from donor site or any other source and maintains accountability via \xe2\x80\xa2 Providing technical leadership and guidance during product transfer ensuring a robust, well understood process is transferred to site \xe2\x80\xa2 Ensuring a well-defined product control strategy is in place and embedded into documents such as SOP- standard operating procedure and manufacturing batch directions \xe2\x80\xa2 Collaborate with R&D to support NPI and ensure seamless transition of product to site During lifecycle management of the product, the Product Owner \xe2\x80\xa2 Actively leads and maintains a cross functional team throughout the lifecycle of the product at site. Review validation documentation (User Requirements Specification, (URS), Installation / Operational qualification documentation (I/OQ), and Performance Qualification (PQ)) for new equipment, technologies and systems as required. Why you? We look for people who appreciate the importance of safety and quality and strive to continuously improve our performance and practices. We work in an open and transparent environment so you\xe2\x80\x99ll be someone who treats others with respect and integrity \xe2\x80\x93 as you will be treated yourself. Ideally, we are looking for someone with:

• Tertiary qualifications in science or related such as pharmaceutical studies, pharmacy, chemistry, engineering or materials science
• Has in depth experience working with manufacturing sites. Demonstrates high commitment to deliver continuous improvement, quality and product robostness
• Able to identify key manufacturing issues, have process and equipment understanding, provide and challenge recommendations for resolution
• Proven track record or expertise in delivery of technical assessments \xc2\xb7 Has thorough knowledge of GMP requirements at manufacturing site and experience in technical, product ownership, product lifecycle management
• Demonstrates ability to contribute to and effectively influence/ work in matrix teams in other functions.
• Has thorough operational and technical knowledge of operational/ laboratory/ plant equipment.
• Demonstrates First Line Leader behaviours
• Understanding of pharmaceutical production process, statistical process control and product knowledge and keep abreast of relevant pharmaceutical technology.
• Understanding of packaging components, packaging process, packaging equipmentand packaging analytical testing if applicable.

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. 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.