QA- Clinical Trial; Senior Executive/assistant Manager (5-8 Years)
3 - 8 YearsBengaluru/Bangalore
Job Description
Job Description:
- Clinical, Non Clinical and Bio Analytical in the Research and Development
- Clinical Trial site, BA/BE Facility Audits, Bio-Analytical and Central Laboratory Audits), Creating Audit Reports and review of Corrective and Preventive Actions provided by Auditee as per applicable (GCP/GLP/GCLP) guidelines and regulatory (EMEA/FDA/DCGI/ICMR) requirements.
- Review of Study related Clinical (Protocol, Informed Consent and Assent, CSR, CRF), Non clinical and Bio-Analytical Documents (Validation as well as test Runs for PK/PD with LCMS, Immunogenicity with RIPA/ELISA) in accordance to applicable regulatory (EMEA/ FDA/ DCGI) Regulations and Guidelines (GCP/GLP/GCLP)
- Review of Submission Dossiers to Regulatory Agencies.
- Performing Quality Assurance Activities like -SOP Creation and Review, Issue and Archiving of Documents as per Quality System followed.
Company Profile
Biocon is an integrated biotechnology enterprise focused on the development of biopharmaceuticals. With successful initiatives in drug discovery and development, bioprocessing, manufacturing and global marketing, Biocon delivers products and solutions to partners and customers in over 75 countries. Biocon has the defining science, world class capabilities and a focused vision to deliver the promise of innovative and affordable medicine to a waiting world. Today, Biocon together with group companies employs more than 5000 employees with approxmimately Rs 2500 crore turnover and is expected to grow further during the current financial year .
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