Manager - Processing (Production)

Manager - Processing (Production)

We are seeking a dynamic and seasoned individual responsible for overseeing day-to-day processing operations in sterile manufacturing, ensuring alignment with production schedules and regulatory standards. The role focuses on identifying process inefficiencies, leading improvement and automation projects, and collaborating with cross-functional teams to drive productivity, reduce waste, and enhance product quality. This position demands strong technical knowledge of sterile processing equipment and a proactive approach to maintaining seamless production workflows and continuous operational improvements.

Location: Umarsadi (Vapi, Gujarat)

Main Tasks:

• Manage and oversee work orders for our 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 on syringe lines.
• 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 entries are 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 adherence to cGMP standards.
• 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.

Requirement:

• M.Pharm /B.Pharm /B.Sc /M.sc / BE (Chemical, Electrical, Instrumentation, Mechanical) from an accredited institution.

Experience:

• Proven record of 12+ years in Junior Management in any Pharmaceutical industry with relevant experience in the area of Process Engineering.

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.

  Contact: careers.hr@schott-poonawalla.com