QMS Compliance

You will be joining Biocon Biologics, a subsidiary of Biocon Ltd, a global biopharmaceuticals company dedicated to developing high-quality, affordable biosimilars to provide advanced therapies to patients worldwide. As a QMS Compliance Team Member, you will play a crucial role in ensuring manufacturing compliance for biosimilars in the following key responsibilities: **Role 1 Manufacturing Compliance (Biosimilars Compliance):** - Investigate microbial excursions for facility, utility, and process. - Prepare contamination control and strategy documents. - Conduct product quality assessments for microbial contaminations. - Develop risk assessment protocols and reports. - Harmonize procedures and practices according to CQA guidance. - Represent manufacturing and coordinate internal & external inspections/audits. - Coordinate audit responses/assessments and implement audit CAPAs. - Drive continuous improvements related to compliance. - Investigate Data Integrity related deviations in the manufacturing function. **Role 2 Microbial Investigator (Biosimilars Compliance):** - Ensure timely conduct of microbial event investigations related to product (deviations, OOS/OOTs) and microbial water excursion (OOS). - Identify root cause analysis and implement appropriate CAPAs to prevent recurrence. - Assess the impact of microbial excursions on ongoing and subsequent batches, proposing recommendations. - Review investigation reports for correctness, evidence-based review, and error-free conclusions. - Participate in management review meetings to present microbial excursions and closure status. - Contribute input during trending of microbial-related deviations and propose recommendations. - Maintain oversight on microbial investigations to ensure global standards consistency and continuous improvement to meet regulatory requirements. **Role 3 QMS (Biosimilars Compliance):** - Manage change controls including initiation, review, implementation, follow-up, and closure. - Oversee CAPA management from initiation to closure. - Handle QMS deviations & incidents through initiation, investigation, and closure processes. - Prepare, review, and close risk assessments related to the manufacturing department. - Complete necessary trainings before executing activities. - Adhere to SOPs, good manufacturing practices, and good documentation practices. This role will require meticulous attention to detail, strong problem-solving skills, and a commitment to upholding regulatory standards to ensure the quality and compliance of biosimilar manufacturing processes at Biocon Biologics.,