Job Description
Downstream Manufacturing Oversight
Lead daytoday downstream insulin processing operations including clarification, purification, and concentration steps.
Ensure compliance with batch records, SOPs, process parameters, and GMP requirements.
Batch Execution Process Monitoring
Monitor critical process parameters CPPs and implement inprocess controls IPCs for consistent product quality.
Coordinate realtime troubleshooting and deviation handling during production.
Team Leadership Shift Management
Supervise operators and shift leads, allocate manpower, and ensure shift continuity.
Train team members on downstream processes, aseptic techniques, and GMP documentation practices.
Compliance Documentation
Ensure timely and accurate documentation of BMRs, logbooks, cleaning records, and deviation reports.
Review and approve production records and support regulatory inspections.
Deviation, CAPA Change Control
Lead investigations for deviations related to downstream operations and implement effective CAPAs.
Support implementation of change controls and continuous improvement initiatives.
CrossFunctional Collaboration
Work closely with QA, QC, Engineering, Validation, and upstream manufacturing teams to ensure seamless process flow.
Support technology transfer and scaleup of new or modified processes.
Audit Readiness
Maintain GMP compliance in the downstream area and support internal, customer, and regulatory audits e.g., USFDA, EMA, WHO.Authorization of batch processing steps and adjustments within allowable process limits.
Manpower and shift allocation based on batch requirements and equipment availability.
Escalation of critical deviations, quality issues, or safety concerns.
Approval of deviation reports, logbooks, and inprocess documentation.
Recommendations for equipment improvements and process optimizations.