Quality Assurance – Clinical Trials
Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where employees have a purpose and passion to work closely with partners and patients. We have a long term commitment to bring high quality affordable biosimilars to patients all over the globe. We have proven end to end expertise from clone development, manufacturing, clinical development, regulatory approvals to commercialization in developed and emerging markets.
- Implement and maintain quality systems to assure compliance with GCP and bioanalysis guidelines
- Prepare, implement and follow procedures for quality assurance processes, and maintain records to demonstrate compliance
- Prepare audit plans/agenda, perform and report vendor, study, trial site and quality system audits (internal and external) to assure compliance with GCP and bioanalysis guidelines
- Be audit ready and face internal, partner, and regulatory audits/inspections
- Review documents and records
- Procedures (SOPs/equivalent)
- Clinical and bioanalytical study protocols and reports, investigator brochures, consent forms, investigational medicinal product (IMP) labels, trial master files, statistical analysis plans, data management plans, bioanalytical method validation plans and reports, bioanalytical sample analysis plans and reports, and associated raw / processed data
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