Processing Manager

We are looking for a dynamic and experienced professional to manage daily operations in sterile manufacturing, ensuring alignment with production schedules and regulatory compliance. The role involves identifying process inefficiencies, driving improvement and automation initiatives, and collaborating with cross-functional teams to enhance productivity, minimize waste, and improve product quality. Strong technical expertise in sterile processing equipment and a proactive approach to continuous operational improvement are essential for success in this position.

Key Responsibilities:

• Manage and oversee work orders for product lines, ensuring efficient execution of production plans to maximize machine performance.
• Plan and implement batch production on a product-specific basis, optimizing throughput and minimizing downtime.
• Collaborate with cross-functional departments to ensure uninterrupted operations and timely execution of preventive maintenance schedules.
• Lead initiatives to reduce market complaints, aiming to maintain a production ratio of over 20 million units per justified complaint.
• Review BMR for new products to be processed.
• Review and approve BMRs for new products prior to processing and verify completed BMRs for submission to Quality Assurance.
• Develop, review, and implement SOPs for syringe processing operations, ensuring thorough training and compliance among line operators.
• Monitor and enhance line yield while working to minimize rejection rates through process improvements and quality control measures.
• Ensure timely preparation of customer samples as per specifications, with accurate documentation in BMRs and logbooks.
• Oversee SAP activities related to batch processing, including data entry, reconciliation, and return of unused materials to inventory..
• Ensure optimal shift-wise performance of SPRC machines, maintaining complete and accurate documentation in SAP, BMRs, and logbooks.
• Prioritize and coordinate the ETO process of completed batches, ensuring all related entriesare updated in both BMRs and SAP.
• Maintain audit readiness by ensuring no critical observations in the production area through strict compliance and monitoring.
• Ensure NVPC records are correctly attached to the respective BMRs and submitted to QA within the designated timeline.
• Lead training programs for staff and operators on cleanroom protocols and enforce
• Ensure full compliance with the most recent EHS guidelines across all production activities.
• Drive continuous improvement of the EHS management system through effective implementation, monitoring, and periodic review.

Education Qualification:

• Mpharm /Bpharm /BSc /Msc / BE (Chemical, Electrical, Instrumentation, Mechanical) from an accredited

institution.

Experience:

• 8-12 years of experience in sterile injectable/aseptic pharmaceutical manufacturing (preferably in processing functions).

Competencies:

• Strong organizational skills and attention to detail.
• In-depth knowledge of sterile processing equipment: Washing Systems, Depyrogenation Tunnels, Sterilizers,
• Siliconization Systems.
• Sound understanding of cGMP, GEP, FDA/ regulatory requirements, and cleanroom operations.
• Strong command over lean manufacturing, root cause analysis, CAPA, and risk assessment tools.
• Strong leadership with proven ability to motivate and guide cross-functional teams.

Skills

• Proficiency in local languages and English, both written and spoken, to facilitate effective communication with employees and stakeholders.
• Knowledge of SAP, MS Excel, PowerPoint, etc.
• Strong learning agility and continuous improvement mindset.