Posted:1 day ago|
Platform:
Work from Office
Full Time
Role & responsibilities 1. Good Experience in overall quality assurance, Must be experienced in facing regulatory audits (ANVISA, USFDA, MHRA,EU,Ukraine,Russia) 2. Responsible for handling of change control, Execution, preparation, Attachments, Log completion. 3. Responsible for Preparation of Process Validation Protocol & Report execution planner of process validation Sampling, critical parameters attributes, establish sample matrix, Intimation TI sheet, collection of all RAW data, attachments of 3 consecutives batches, attachments of analytical reports. 4. Responsible for handling Deviation, Execution, preparation, Approval, Closure, managing logs. 5. Responsible for Market complaint, Investigation, find out root cause, Conclusion, preparing backup data, attachments, Closure, manage logs. 6. Responsible for Self-inspection report & conduct Self inspection, rotate circular, selection of auditors, preparation of checklist, Execution of self-inspection, prepare CAPA for Noncompliance, Review and verification of all Data. 7. Execution of Cleaning validation and review of Method Validation protocol. 8. Responsible for CAPA, preparation of CAPA, collecting data, investigation, closure of CAPA, manage logs. Preferred candidate profile 1. Candidate should preferrably from Pharma Industry 2. Strong in regulatory compliances
Bhargava Phytolab
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