Description:

Job 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.