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I/c- Product Enhancement Group- Injectable
3 months ago
- MORAIYA
- Job posted on
Jan 4, 202
- Employment type
- P-P8Probationer-HO Executive
- Experience range
- 8 years 12 years
ZTMP - REQUEST FORMAT
Name :
Akanksha Dham
BU :
Tech - Ops (From.) Mfg
Place :
Zydus Lifesciences Ltd., Moraiya, Ahmedabad
Basic Details:
Position :
I/C- MS&T
Designation :
Assistant/ Deputy Manager
Reports to :
Head
- PEG
Department :
Product Enhancement Group
Location :
Moraiya, Ahmedabad
No of Posts : 1
KeyJob Description:
- Perform Quality Risk assessment in new products under launch as well as ongoing commercial products & communicate the Risk to Senior Management for taking appropriate measures for mitigation.
- Ensure the identification of CQAs and CPPs & assess the risks in the ongoing products as well as new products and processes on the shop floor.
- Review & compute Process capability to understand the health of product and identify the batches which are contributing towards Poor capability index. Communicate the early risks identified by poor capability index to respective heads and Production and Site quality heads.
- Identify and recommend any additional In
- Ensure the detailed assessment of all historical data to identify opportunity areas including validation reports, annual product quality report, market complaints, out of specification, deviations, product development reports, batch manufacturing reports, specifications, and design elements, etc.
- Prepare & review the final Risk Assessment Reports before PPQ batches as well as for Legacy products, across cross-functional teams, as & when required.
- To ensure setting up cross-functional discussions, and alignment building among all the stakeholders including senior management.
- To ensure the use of appropriate tools to track and communicate the progress of the project and timely highlight risks in the delivery of the project on time to all the stakeholders.
- Effectively and wisely use escalation mechanism to get issues de-risked with the HODs of CFTs.
Requirements:
Qualification :
M.Pharma
Total Years of Experience : 8- 12 Years
Experience in Zydus :
Min. One Year
