Biocon Limited
Designation : Assistant Manager
Function : QA
Functional Area : Quality Assurance
Job Role Summary : Process Validation / Cleaning Validation Team Member
Job Profile :
- Responsible for Preparation and Review of Process validation/Verification protocol and report.
- Preparation and Review of cleaning validation/verification protocol and report.
- Preparation and review of master validation schedule.
- Support to the Customer audits/ Regulatory Inspections/ Internal Audits.
- Review of master validation BMR/ECC/PDRs. Review of and approval of executed validation BMR/ECC/PDRs.
- Handling material destruction activities.
- Preparation and review of QMS trend analysis reports. Review and approval of risk assessment protocol and reports.
- Preparation of DH, CHT protocol and establishment of equipment hold time.
- Preparation of QMS information for Management Review meeting.
Job Requirements :
6-10 years of QA experience in Pharma API
Work / Job Experience : 6-10 Years
Type of Experience : Pharma API QA experience
Academic Qualifications :
MSc
