Website Zydus Group Ltd
Post Name: MS&T- PEG Product Risk Assessment
Division: Moraiya
Department: MS&T
Category: Staff
Qualification: B.Pharma/M.Pharma
Experience: 3 – 8 Years (OSD &/ Topical)
Experience at Zydus: 24 Months
Job Responsibilities:
Quality Risk assessment in New products under launch as well as on-going commercial products & communicate the risks to Senior Management for taking appropriate measures for mitigation. Identification of CQAs and CPPs & assess the risks in the on-going products as well new products and processes at the shop floor. (OSD and/or Topicals)
Review & compute Process capability to understand the health of products and identify the factors which are contributing towards Poor capability index. Communicate the early risks identified by poor capability index to respective heads along with Production and Site quality heads.
Identify and recommend any additional in- process tests or studies at the shop floor to avoid OOS/OOT.
To ensure the detailed assessment of all historical data including validation reports, annual product quality report, market complaints, out of specification, deviations, product development report, batch manufacturing report, specifications and design elements etc. to identify opportunity areas
To prepare & review the final risk assessment reports before PPQ batches as well as for Legacy products.
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 project.
Develop detailed project plan to monitor and track progress by the Project Management Executives.
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.
To escalate the issues related to the process, product, quality, cleaning process or documentation related activities to his immediate supervisor and take the appropriate action related to it.
To escalate any failures and overdue activity that can have a potential impact on product quality to his immediate reporting authority.
Effectively and wisely use escalation mechanism to get issues de-risked with the HODs of CFTs.
Planning and monitoring the trial/engineering batches and preparation of reports
Evaluation and assessment of stability data identify the risks and suggest mitigation plan
In depth knowledge of equipment and manufacturing operations along with batch size scale up/ scale down
Investigation of legacy product based on CPV trend and suggest the mitigation plan to keep the product in status of control throughout the product life cycle.
