Technical Product Lead

The Technical Product Lead provides technical leadership and is accountable for product lifecycle management, technical transfer and new product introductions from site. This role is also accountable for validation oversight, management and delivery of all Validation Lifecycle components at KL site.

Key Responsibilities

• Accountable for Product / Process assessments and continuous improvement at site.
• Accountable for product transfer, new product introduction (NPI) and technical oversight and accountability ensuring a robust process is transferred within a well defined and appropriate Product Control Strategy
• Provide Technical leadership, engage and drive performance of the Product and process engineers within the technical team and engage wider Haleon Technical network for support
• Troubleshooting and CAPA implementation / effectiveness for technical related issues
• Ensuring all aspects of Product Quality Lifecycle Management are actively applied to the products at site
• Accountable for oversight, management, and delivery of all Validation Lifecycle components. Provides guidance and support on validation, in terms of standards, approach and execution. As the validation expert, supports internal and external audits ensuring successful outcome and site can demonstrate system compliance to a regulatory auditor.
• Understands and ensures compliance to evolving expectations of: Equipment and Facility C&Q, Process/Packaging validation, Cleaning validation, Continued Process validation (CPV), Analytical Method validation, and Computer System validation
• Maintains and ensures site validation master plan (SVMP) adherence. Identify quality risks in validation projects and supports risk mitigation. Facilitates validation Risk assessment and deviation investigation.

Education Background

• BS degree in a related scientific or technical discipline such as chemical engineering, chemistry, pharmacy or pharmaceutical engineering
• Technical troubleshooting, facilitate process and equipment understanding, provide and challenge recommendations for resolution
• Masters / PhD in Science or Engineering field of study and / or Business

Job Related Experience

• Minimum of 5 years of demonstrated experience in OTC, pharmaceutical, or FMCG manufacturing / technical environment.
• Hands on experience working with Oral Solid Dose (OSD), pharmaceutical products and manufacturing operations.
• Skilled in technology transfer, with an understanding of the product development process – working knowledge of technical risk assessment (TRA) tools and activities.
• Well versed in overall validation lifecycle including cleaning validation lifecycle
• Proven track record in problem solving
• Role requires strong understanding of OSD product functional /physical properties and impact on product performance, excipient functionality and material characterization.
• Have a thorough appreciation of quality assurance, global quality procedures, validation principles and regulatory requirements.
• Ability to communicate, negotiate with and influence effectively all levels of management in the internal and external environment.
• Ability to interpret complex data and translate into simple summaries and recommendations
• A broad business understanding to ensure robust business and supply chain risk management.