Zydus Lifesciences Limited
Designation : Executive
Function : TECHNICAL OPERATIONS- PRODUCT ENHANCEMENT GROUP
Functional Area : MS&T
Job Role Summary : The job holder is an important member of the Product Enhancement Group within the Global MS&T function. Person will be handling products across multiple/One manufacturing sites for multiple markets including USA and Europe
Job Profile :
- Perform Risk assessment for New Products Launch as well as for ongoing commercial products. Propose appropriate mitigation actions in consultations with the cross functional teams.
- Review & compute process capability to understand the health of products and identify the batches which are contributing towards poor capability index. Communicate the early risks identified to respective heads along with production and site quality heads.
- Identify and recommend any additional In-process tests at the shop floor to avoid OOS/OOT.
- Ensure the detailed assessment of all historical data, including from validation reports, annual product quality reports, market complaints, out of specification, deviations, product development report, batch manufacturing records, specifications and design elements etc to identify improvement areas
- Prepare & review the final risk assessment reports before validation batches for new products.
- Lead to drive projects with project team members by ensuring effective utilization of resources, setting up internal milestones to ensure completion on time.
- Ensure setting up cross functional discussions, alignment building among all the stakeholders including senior management.
- Ensure sign-off from all the stakeholders along with the timeline commitments on delivery of the projects.
- Develop detailed project plans to monitor and track progress by the Project Management Executives.
- Ensure the use of appropriate tools to track and communicate progress of the projects and highlight risks in the delivery of the projects on time to all the stakeholders.
Job Requirements :
- 5 years - 10 years
- Experience in reviewing product and process performance and risk assessment, reviewing historical trends and project early risks
- Product and Process understanding, Understanding of regulatory and GMP requirements
Work / Job Experience : 5-10 Years
Type of Experience : Product risk assessment, process capability, assessment of all historical data, recommend In-process tests to avoid OOS, OOT
Academic Qualifications :
Graduates, Post graduates in Life Sciences, Engineering
