Job Description

Job Description: Educational and Experience Requirements: Education: Bachelor s degree in pharmacy (B Pharm) or Chemical Engineering. Graduated from a reputed university or college, such as NITs, RECs, or Tier-1 state colleges. Experience: 3 to 7 years of experience in manufacturing or production. Job Description Mixing and Filling Operations Expert in liquid-liquid and solid-liquid mixing and filling processes. Proficient in packaging operations with a focus on accuracy, hygiene, and efficiency. Regulatory Compliance Implement and oversee manufacturing practices in strict adherence to FDA , WHO , and cGMP guidelines. Ensure processes meet global quality and safety standards . Project Management Successfully managed projects aimed at cycle time reduction , productivity improvements , and line balancing . Demonstrated ability to drive cross-functional teams towards project milestones and KPIs. Safety & Risk Analysis Conduct Pre-Startup Safety Reviews (PSI) , HAZOP , and Process Hazard Analysis (PHA) for new product introductions. Lead all Process Hazard Management activities for existing products to ensure safe and reliable operations. Process Analysis & Optimization Perform process capability studies , What-if analyses , and variability studies to optimize performance. Define and refine key process parameters such as cycle time , lead time , takt time , and line balancing . Process & Equipment Qualification Lead and support process qualifications , change control , and IQ/OQ (Installation & Operational Qualification) . Accountable for equipment calibration and maintaining validation records. Operational Excellence Foster shop floor discipline , team engagement , and a culture of 5S , system adherence, and compliance. Drive continuous improvement through SPC (Statistical Process Control) and process mapping . Documentation & Training Manage production reporting and ensure all process documentation is up to date. Conduct training programs for team members on SOPs and best practices. Customer-Centric Quality Management Conduct root cause analyses for customer complaints and deviations. Implement Corrective and Preventive Actions (CAPA) to drive continuous quality improvements. Operational Management Monitor and maintain line flow , output , and process control for optimal production efficiency. Capacity Planning & Resource Management Develop and execute capacity plans , shift planning , material issuance , and manpower loading . Use SAP applications (preferred) for planning, tracking, and analysis. Improvement Initiatives Spearhead yield improvement , OEE (Overall Equipment Effectiveness) , and automation projects. Apply Industrial Engineering techniques like cycle time , method , and work studies to improve productivity, quality, and safety. Process Redesign & Layout Optimization Identify opportunities and implement process redesigns , layout modifications , and workflow enhancements to boost efficiency and reduce waste. 1. Certifications Six Sigma Green Belt certification is preferred (not mandatory). 2. Regulatory & Industry Compliance Proven experience working with FDA , WHO , and cGMP standards. Sound understanding of ICH and WHO guidelines related to pharmaceutical manufacturing and quality systems. 3. Technical Proficiency Hands-on experience in commissioning and qualification processes (IQ, OQ, PQ). Familiarity with validation protocols and regulatory documentation. 4. Industry Exposure Demonstrated exposure to the pharmaceutical and healthcare industries, preferably in manufacturing or process engineering roles. 5. Corporate Experience Experience working in multinational corporations (MNCs) is preferred. Ability to work within structured environments and adhere to global corporate policies. 6. Career Stability Shows a stable career progression with limited job-hopping. Preference for candidates with long-term tenures in previous roles, reflecting reliability and commitment.