senior executive

1 week ago


India BIOCON PHARMA LIMITED Full time

Department Details

Role Summary

Sr. Executive - Analytical Quality Assurance

Key Responsibilities

"
•Designing, implementing & strengthening PQS like training, deviation, laboratory incident, change control, CAPA, effectiveness check, internal audit, external audit, QRM & training etc. and achieve score card in state of control and periodic review at R&D.

•Ensure the Good Documentation Practices and Data Integrity principles at the workplace to propagate & reinforce the Quality culture throughout the R&D.

•Preparation, revision and approval of SOP's and related guidance.

•Review and approval of qualification / requalification activities, calibration schedule and PMP schedule.

•Review and approval of different analytical documents to assure completeness and compliance. Review & approval of different formulation documents based on requirement.

•Handling of document management system.

•Quality support to developmental activities at R & D to ensure that the data and technology transfer to commercialization sites are accurate, adequate & robust.

•To assess the developmental, process, data and technology that are built on QbD & QRM principles.

•Handling of regulatory queries and on time support for any regulatory and ROW filing.

•Support to all projects & technology transfers to be transferred are completed in a timely manner.

•Deployment of digitalisation at R&D as per business requirement.

•Ontime support to BPL manufacturing site / other sites as and when required.

•Carryout all other activities as assigned by the head of department"

Educational Qualifications

Required Education Qualification:
Required Experience: 5 - 7 years



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