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| Position |
Product Owner |
| Company Info |
欧洲大型制药企业 |
| Responsibilities |
Key Accountabilities/Responsibilities:
¨ Responsible for understanding, managing and influencing the technical elements of the product lifecycle on behalf of GMS. These technical elements may comprise of formulation, manufacturing process, analytical process and packing.
¨ Manage technology transfer from R&D into GMS and subsequent transfers to other sites.
¨ Establish and maintain product knowledge expertise, ensuring critical processing knowledge is translated effectively to operational personnel and others as required.
¨ Responsible for risk management, change management and knowledge management associated with their product portfolio.
¨ Develop PUCC program, ensuring process understanding, control and capability are constantly enhanced throughout product lifecycle.
¨ May be responsible for the direct management of Product Technologists.
Work closely with respective departments and regulatory affairs to ensure continued technical compliance to sFDA requirements for product introduction and registration.
¨ Provides lead technical input during technology transfer activities, working closely with site’s project manager
¨ Works with the entire supply chain (including primary and excipient suppliers) to optimize the technical performance of allocated products within manufacturing, packaging and lab testing.
¨ Identifies Critical Process Parameters (CPPs) and if not previously identified through DFM, the Critical Quality Attributes (CQAs), ensuring that these are understood, controlled and verified.
¨ Trends product performance and acts on process drift (including stability).
¨ Ensures that product knowledge is created, captured, applied, stored, available, shared and refreshed across the product lifecycle, product knowledge repository is critical. Provide training materials to appropriate groups.
¨ Provide technical leadership to major product failure investigations, in conjunction with QA, escalating significant issues to ensure appropriate expertise is engaged.
¨ Contributes to technology development projects aligned to allocated products including the harmonisation of equipment and processes across actives, secondary and R&D.
¨ Works closely with PSS and key suppliers to develop meaningful specifications for key process inputs, namely API and excipients, thereafter ensures agreed functional specifications are supported
¨ Provides lead site technical input to regulatory submissions and participates in regulatory negotiations with the sFDA and other regulatory bodies.
Leads projects associated with PUCC whilst actively observing processes in production and analytical testing ensuring that the relevant control and verification strategies are deployed and used effectively
Qualifications & requirements:
¨ BSc, MSc or PhD in a related scientific or technical discipline such as chemical engineering, chemistry, pharmacy, or pharmaceutical sciences
¨ Competent in all unit operations associated with manufacturing, preferably versed in biopharmaceutics and understands the impact of process and material changes on product and patient performance.
¨ Detailed knowledge of relevant dose form, unit operation understanding, formulation science, device/packaging processes and analytical testing
¨ Experienced in technology transfer, with an understanding of the drug development process,
¨ Understanding of DFM principles and FIPG
¨ Proven ability to communicate, negotiate with and influence effectively all levels of management |
| Requirements |
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| Update |
2014-09-26 |
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