Manager
4 days ago
Biocon Biologics
is a fully integrated 'pure play' biosimilars organization globally committed towards transforming patient lives through innovative and inclusive healthcare solutions. It is engaged in developing high-quality, affordable biosimilars aimed at expanding patient access to cutting-edge class of therapies across the world. Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led-global biopharmaceuticals company and India's first publicly listed biotech enterprise. Biocon Biologics has one of the largest biosimilars portfolios, a wide global footprint, state-of-the-art manufacturing facilities, world-class R&D ecosystem, and high quality & compliance standards, enabling it to fulfil unmet needs of patients across the globe.
Responsibilities
Packing Operations
- Supervise and manage packing lines (Vi/Packing) to meet quality standards.
- Monitor packing operations to ensure correct labelling, batch coding and packing.
- Coordinate with QA/QC for batch release and documentation compliance.
- Maintain compliance with GMP and regulatory standards.
- Track and report batch-wise packaging progress.
- Monitor packing line performance and equipment efficiency.
- Coordinate with QA for in-process checks and documentation.
- Maintain cleanroom protocols and packing records.
- Coordinate with formulation, filling, and inspection teams for smooth operations.
Production Planning (Injectables)
- Develop and maintain daily, weekly, and monthly production plans for injectable products.
- Coordinate with SCM, warehouse, quality assurance, and manufacturing teams to ensure material/SFG availability.
- Monitor production progress and adjust schedules to meet delivery timelines.
- Optimize resource utilization including manpower, equipment, and materials.
- Analyze production data to identify bottlenecks and implement corrective actions.
- Prepare MIS reports and dashboards for senior management review.
Quality Management System
- Investigate Market complaints and non-conformance investigations.
- Ensure timely updates and revisions to SOPs.
- Coordinate with cross-functional teams to resolve quality issues and implement improvements.
- Monitor and analyze quality performance metrics, report findings to senior management.
Preferred Skill's
- Experience in handling regulatory audits (USFDA, MHRA, etc.).
- Strong leadership and team coordination abilities.
- Ability to work and manage multiple priorities.
- Knowledge of Lean Manufacturing and Six Sigma principles.
Qualifications
- Bachelor's degree or equivalent experience
- Microsoft Office (Outlook, Excel, Word, PowerPoint, etc.) Organized
- Strong leadership skills
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