About the role
1. To prepare protocol and reports for process validation (Process Performance Qualification), cleaning validation, packing validation and hold time study.
2. To co-ordinate with cross functional team like IPQA, production, quality control etc. for execution of validation and hold time activities.
3. To track the batches for process validation, cleaning validation, packing validation and hold time study.
4. To prepare schedule for continuous process verification. To perform continuous process verification for the product as per SOP. To prepare continuous process verification protocols and report of product.
5. To review statistical annexures of critical process parameters, critical quality attributes and yield in continuous process verification reports.
6. To prepare and review qualification / requalification protocol & reports, monitor the qualification activities.