Biocon Biologics Recruiting For Manufacturing QA Position. Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company. Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally. It is uniquely positioned as a fully integrated ‘pure play’ biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions.
Eligibility and other details :Â
- Post Name: Manufacturing QA
- Qualification: B.Sc,M.Sc,M. Pharm with 12-15 years hands-on experienceÂ
- Location: Bengaluru
- Salary:Not Disclosed
- No Vacancies: 01
- Selection Process : Based on Resume Received,will shortlist.
Job description:
- 1. Establish and maintain the global quality system 2. Ensure quality oversight on all process documents and systems, to ensure consistency of global standards, harmonization, sharing of best practice and productivity 3. Drive continuous improvement of the quality system to meet and sustain compliance with internal and external regulatory requirements 4.Conduct Quality reviews to evaluate if process and deliverables fulfills requirements of quality. 5. Oversee deviations, investigation and audits, involve in regulatory and customer audits. 6. Overall monitoring of quality activities in the area of DSP & USP operations. 7.Review of internal GMP rounds report / inspection outcome and review of action plan in all the sites. 8.Review and approve MFR, BMR, SOPs, experiment study protocol/report, qualification document. 9. Ensure review and closure of discrepancy, change control, risk assessment, OOS, OOT, and CAPA effectiveness. 10. Review Process Validation and Cleaning Validation protocol for DS manufacturing facility and report closure on time as per regulatory guidelines.
