Educational Qualification: BTech/MSc/MTech
Experience: 2 -3 years
No of position: 01
Job Location : Bengaluru, India
- Shop floor Monitoring and execution of day to day activities of Manufacturing of drug substance.
- Handling of line clearance and dispensing activities (Drug Substances)
- Preparation, Review of Batch production records, Log registers and raw data sheets.
- Preparation and review of SOPS.
- Preparation and review of study protocols.
- Handling of deviations and its investigation and root cause analysis.
- Handling of CAPA and verification of CAPA effectiveness.
- Handling of change control assessments and verification of implementation status.
- Handling of self-inspections and its follow up.
- Review and online verification of the executed batch records.
- Knowledge on compliant investigation procedure.
- Knowledge on batch release procedures.
- Knowledge on cleaning validation and process validations.
- Knowledge on regulatory guidelines (WHO, FDA, and ICH etc.)
- Experience in handling of regulatory audits and customer audits (WHO/FDA)
- Knowledge on data integrity procedures/management.
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Please share the resumes on or before 21/01/2019