Production Planning & Execution: Oversee the daily production schedule for GranulationCompressionand Coating to ensure timely delivery of batches as per theMonthly Production Plan.
BMR/BPR Review & Data Integrity: Perform a thorough technical review ofBatch Manufacturing Records (BMR) andBatch Packing Records (BPR) to ensure 100% compliance with ALCOA principles.
QMS Ownership: Lead the investigation and documentation ofDeviations Change Controls and CAPAs.Ensure all Out of Specification (OOS) incidents in production are addressed and closed.
Yield & Resource Optimization: Analyze batch yields and reconciliation data; implement process improvements to reduce rejection rates and optimize manpower and machine utility.
Audit Management: Represent the production department during internal and external audits (e.g.USFDA MHRA TGA WHO).Defend process deviations and explain shop-floor practices to auditors.
Team Leadership & Training: Supervise and train a team of Operators and Junior Executives on updatedSOPs cGMP and Safety protocols ensuring a culture of high performance and quality.
Required Experience:
Senior IC
Production Planning & Execution: Oversee the daily production schedule for GranulationCompressionand Coating to ensure timely delivery of batches as per theMonthly Production Plan.BMR/BPR Review & Data Integrity: Perform a thorough technical review ofBatch Manufacturing Records (BMR) andBatch Packin...
Production Planning & Execution: Oversee the daily production schedule for GranulationCompressionand Coating to ensure timely delivery of batches as per theMonthly Production Plan.
BMR/BPR Review & Data Integrity: Perform a thorough technical review ofBatch Manufacturing Records (BMR) andBatch Packing Records (BPR) to ensure 100% compliance with ALCOA principles.
QMS Ownership: Lead the investigation and documentation ofDeviations Change Controls and CAPAs.Ensure all Out of Specification (OOS) incidents in production are addressed and closed.
Yield & Resource Optimization: Analyze batch yields and reconciliation data; implement process improvements to reduce rejection rates and optimize manpower and machine utility.
Audit Management: Represent the production department during internal and external audits (e.g.USFDA MHRA TGA WHO).Defend process deviations and explain shop-floor practices to auditors.
Team Leadership & Training: Supervise and train a team of Operators and Junior Executives on updatedSOPs cGMP and Safety protocols ensuring a culture of high performance and quality.
Required Experience:
Senior IC
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