MSAT Product Owner

🔥 0 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

✅ Product Manager

👻 Ghost score 10%

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GSK

WebsiteLinkedInAll Job Openings

10,000+ employees

🏭 Manufacturing

💊 Pharmaceuticals

🏥 Healthcare

Manufacturing • Pharmaceuticals • Healthcare

GSK is a global healthcare company focused on uniting science, technology, and talent to advance pharmaceutical products and vaccines. With a commitment to innovation, GSK aims to provide solutions that help manage and prevent diseases, improving health outcomes for patients worldwide.

📋 Description

• Manage and deliver the solid oral, liquid, sterile and topical dosage product portfolio • Own and provide technical leadership for products or product families at local and/or global level • Serve as Technical Product Owner throughout the product lifecycle • Lead new product introductions, technology transfers, scale-up, validation and handover to manufacturing sites and contract partners • Own product technical knowledge, performance monitoring, process capability, robustness and continuous process verification • Assess and approve technical changes using risk management tools • Maintain current product control strategies and mitigation plans • Lead investigations and root-cause analysis for deviations, complaints, CAPAs, audit findings and complex product-performance issues • Prepare and review risk assessments, specifications, validation reports, qualification documents and periodic product reviews • Support PLM lead with implementation and sustainability • Support statistical analysis and statistical capability building in ES India • Collaborate with Quality, Operations, Engineering, R&D, suppliers and global sites • Coach teams and strengthen technical and statistical capabilities

🎯 Requirements

• M. Pharm. (Pharmaceutics) with up to 5 years of experience • Specialisation in pharmaceutical manufacturing, technical operations, MSAT or product ownership • Experience in new product introduction, technology transfer or lifecycle management • Experience leading technical investigations, root cause analysis and corrective actions • Experience leading technical aspects of the product lifecycle, including technology transfers, technical risk assessments, product control strategies, process capability/robustness, QbD, validation and change control • Knowledge of Good Manufacturing Practices (GMP) and product quality requirements • Capability to lead line and matrix teams in a technical role • Knowledge of external regulatory requirements, including MHRA and FDA • Knowledge of product dosage forms and manufacturing processes • Familiarity with data analysis, statistical tools or digital product lifecycle tools • Experience working in a matrix organisation across geographies and cultures • Project management and resource management skills • Ability to use and interpret data for tactical and strategic decision-making • Knowledge of operational excellence tools such as FMEA and MSA • Experience with packaging components, primary containers or device qualification • Experience in sterile, liquid, solid or topical dosage forms • Experience with validation protocols, qualification activities and risk assessments • Experience with process validation, scale-up and technical transfer • Knowledge of dosage-form unit operations, formulation-material functionality and criticality, plant equipment and analytical testing • Level 1 Practitioner for TRAs, or understanding of PLM toolsets and their site benefits • Knowledge of regulatory environments in product markets • Track record of product/process improvement and technical trials and validation activities • Thorough knowledge of GMP and EHS requirements • Ability to assess and interpret statistical data, including process capability, control charts, DoE and MSA • Strong English communication skills and technical report writing ability

🏖️ Benefits

• Inclusion and recruitment-process adjustments available upon request • Opportunity to work for a global biopharma company focused on specialty medicines and vaccines • Environment intended to support employee growth and wellbeing