- Location
- Kuala Lumpur, Malaysia
- Type
- Full-time
- Department
- Engineering
- Closing date
- Today
- Source
- Workday
Description
Welcome to Haleon. We’re a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In just three years since our launch, we’ve grown, evolved and are now entering an exciting new chapter – one filled with bold ambitions and enormous opportunity.
Our trusted portfolio of brands – including Sensodyne®, Panadol®, Advil®, Voltaren®, Theraflu®, Otrivin®, and Centrum® – lead in resilient and growing categories. What sets us apart is our unique blend of deep human understanding and trusted science.
Now it’s time to fully realise the full potential of our business and our people. We do this through our Win as One strategy. It puts our purpose – to deliver better everyday health with humanity – at the heart of everything we do. It unites us, inspires us, and challenges us to be better every day, driven by our agile, performance-focused culture.
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.
Key Responsibilities (Recommended: 10 bullet points maximum)
Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role
1. Own the product, be the subject matter expert or ‘go to’ person, provide technical leadership and advice on product or products under product owner’s portfolio,
- Ensure all aspects of PLM- product lifecycle management are in place and are actively maintained.
- Perform Techinical 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
2.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.
3. 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.
4.In a New Product Introduction (NPI), take accountability from donor site or any other source and maintains accountability via
- Providing technical leadership and guidance during product transfer ensuring a robust, well understood process is transferred to site
- Ensuring a well-defined product control strategy is in place and embedded into documents such as SOP- standard operating procedure and manufacturing batch directions
- Collaborate with R&D to support NPI and ensure seamless transition of product to site
5.During lifecycle management of the product, the Product Owner
- Actively leads and maintains a cross functional team throughout the lifecycle of the product at site.
- Is E2E accountable for the Process Design Stage ( Stage 1 ) by leading the wholistic TRA, FMEA, CVRA, trials, Design Of Experiments (DoE), ensuring that the risk is identified and properly mitigated prior to the execution of the Process Qualification( Stage 2 of PQ).
- Is accountable for the technical input into the lifecycle validation approach of the product
- Is E2E accountable for the Process Qualfication Stage ( Stage 2) by leading the execution of the Process (PV) and Cleaning Validation (CV) activities ensuring a risk based approach that enables results Right First Time
- Works with operations management to translate that well-defined product control strategy into clear manufacturing batch directions
- Works with operational quality to ensure that the specification and analytical methodologies are in place and appropriately used, deviation and laboratory data are regularly reviewed, provides technical leadership and input into the root cause analyses in support of the investigation and resolution of product deviations,complaints etc.
- Pro-actively monitors the manufacturing and analytical performance of the product, including stability data ( provided by the Site QC), highlighting and investigating performance drifts or out of trends to the Continuous Process Verification Board and making recommendations for continuous improvement, providing updates ( highlights or lowlights) at the Site Quality Council.
- Ensures that all aspects of the product quality lifecycle management are in place and maintained such as PCS, TRA, CPV, proactive data trending.
- Ensures risk and mitigation are in place, executed as appropriate and agreed with Site/ Regional Quality Councils.
- Coordinates input into the site Product Quality Risk Management process (PQRM)
- Provides technical input into the Periodic Product Review report, regulatory submissions and annual reports
- Lead and or provides technical inputs, Continuous Improvement activities or leads value engineering (VE) activities that can drive product performance, efficiency, cost saving opportunities.
- If in a supervisory product owner role is applicable, provides guidance, training to develop capability in areas of technical expertise such as (TRA, PCS, DoE, CV, PV, statistics, Continuous Improvement Framework (CIF), VE to other product owners
- Participates in PTRT, Community of Practice (CoP) or similar forum within the technical community as applicable
- Demonstrates First Line Leader behaviours
- Supports and drives Zero accident culture in the shopfloor by promoting EHS behaviour, support ergonomic or process safety improvements by implementing mitigations in manufacturing, cleaning activities that possess safety risks.
6. 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
Job Posting End Date
2026-09-13
Equal Opportunities
Haleon are committed to mobilising our purpose in a way that represents the diverse consumers and communities who rely on our brands every day. It guides us in creating an inclusive culture, where different backgrounds and views are valued and respected – all in support of understanding and best serving the needs of our consumers and unleashing the full potential of our people. It’s important to us that Haleon is a place where all our employees feel they truly belong.
During the application process, we may ask you to share some personal information, which is entirely voluntary. This information ensures we meet certain regulatory and reporting obligations and supports the development, refinement, and execution of our inclusion and belonging programmes that are open to all Haleon employees.
The personal information you provide will be kept confidential, used only for legitimate business purposes, and will never be used in making any employment decisions, including hiring decisions.
Adjustment or Accommodations Request
If you require a reasonable adjustment or 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 adjustments you are requesting. We’ll provide all reasonable adjustments to support you throughout the recruitment process and treat all information you provide us in confidence.
Note to candidates
The Haleon recruitment team will contact you using a Haleon email account (@haleon.com). If you are not sure whether the email you received is from Haleon, please get in touch.