IPL Biologicals

Summary:We are seeking a highly experienced DGM to lead Quality Assurance and operational excellence, specifically within a manufacturing environment dealing with microbial-based products. This role mandates extensive knowledge of fungal and bacterial submerged fermentation, contamination control, and downstream processes (centrifugation, freeze-drying). Key responsibilities (60% focus) include maintaining quality from lab scale to dispatch, ensuring compliance with ISO/INDOCERT/GMP standards, driving process optimization for new and existing products, leading RCA for operational incidents, and managing cost-saving projects.Key Responsibilities and Technical Deliverables:Product Quality and Compliance (60%):- Ensure basic principles of compliances are implemented and adhered to across the entire value chain: raw material handling, processing, packaging, and dispatch of finished goods.- Maintain the Quality at all levels (lab scale to commercial scale), performing checks on raw material, in-process samples, harvest samples, finished products, packaging quality, and dispatch quality.- Demonstrate mandatory Knowledge on microbial based procedure including fungal & bacterial based submerged fermentation.- Implement stringent Fermentation process controls for contamination free product, ensuring zero contamination from strain to finished products through strict process controls.- Reduce the contamination failure in any inoculum process, fermentation process, bottle filling process, and mixing, through active contamination control methods.- Apply Knowledge on contamination control during process and at filling, mixing, and downstream processes.- Knowledge on downstream processes like centrifugation (bacterial and fungal) and Freeze drying (Bacterial and fungal).- Following the ISO, IMO, INDOCERT guidelines to improve the quality standards and actively conduct external and internal audits.- Maintenance & SOPs implementation for clean room environments.- Shelf life of the product checking up to 2 years and maintaining back samples at the in-house lab.Productivity, Process Improvement, and Cost Management (25%):- Planning, organizing Schedules & overseeing production process to ensure quality output and efficiency.- Analyze daily production reports for determining efficiency and productivity, focusing on minimizing wastage as per Plant KPIs.- Lead and implement Technical procedures & standards for operation and maintenance of equipment, including a Preventive Maintenance System.- Manage the Repair & Maintenance Budget, lead Cost Saving, and Productivity Improvement Projects.- Proactively analyze and reduce re-occurrence of break-downs by carrying out RCA (Root Cause Analysis) within the team.- New product process optimization for commercial production, including validation of cultures every three months.Manpower, Safety, and Housekeeping (10%):- Ensure ample manpower capacity (contractual and regular) and proper manpower schedules for smooth plant operation and product delivery.- Mentoring and imparting technical training/knowledge to staff for better working and enforcing good product handling practices.- Conducting safety training to prevent accidental injuries, ensure adherence to safety policies, and investigate any accident or safety violation with corrective measures.- Maintain and upkeep of Plant hygiene by ensuring good manufacturing practices (GMP) all the time.- To carry out continuous improvement in area of operation for improving safe work environment.Customer Satisfaction and Logistics (5%):- Ensure customer satisfaction by delivering products, services, and information with promptness and accuracy.- Understand service quality index (SQI) and make meaningful contribution in continuous improvements.- Implement FIFO System in raw materials, packaging materials, WIP, SFG, and FG inventory management.- Should be involved in input quality control system of raw materials, packaging materials, and chemicals.- Should be involved in logistics and materials have to be dispatched of good quality as per accepted parameters.Mandatory Skills & Qualifications:- Microbial QA: Mandatory Knowledge on microbial based procedure (fungal & bacterial submerged fermentation) and contamination control.- Process Expertise: Expertise in Fermentation process controls and downstream processes (centrifugation, freeze drying).- Compliance: Experience in following and auditing ISO, IMO, INDOCERT guidelines and GMP/Clean Room procedures.- Management: Proven experience in Planning, organizing Schedules, RCA, and Productivity Improvement Projects.- Inventory: Ability to Implement FIFO System across materials and finished goods.Preferred Skills:- Experience with Quality Management Systems (QMS) software.- Certification in relevant quality standards or safety management.- Experience in process automation implementation for quality control and packaging.- Strong background in chemical or biochemical engineering for process analysis. 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