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I further attest that all information I submit in my employment application is true to the best of my knowledge.<h2>Job Description</h2>Qualification: B.E./ B Tech (Chemical Engineering)Experience: Minimum 8 to 10 years in API manufacturing PlantJob Responsibilities:<ul><li>Plan batches as per monthly production schedules, allocate jobs across shifts, and supervise shop floor activities to ensure compliance with batch manufacturing records (BMR).</li><li>Ensure timely availability of raw and packaging materials by raising SAP requests, verifying received quantities, and maintaining proper yield and quality at all stages of production.</li><li>Prepare, update, and maintain BMR, BPR, cleaning records, equipment logs, SOPs, and other production-related documents, ensuring submission to QA on time.</li><li>Coordinate with departments (Engineering, IPQC, warehouse) to ensure smooth plant operations and verify in-process sample results (IPQC).</li><li>Manage and complete SAP-related entries for running batches in shift, including creation and tracking of purchase requisitions.</li><li>Report process deviations, raise necessary change controls, and supervise proper hazardous waste disposal to ensure compliance.</li><li>Enforce safety protocols for personnel, maintain inventory of PPEs, and report incidents/accidents to the plant in-charge.</li><li>Raise and follow up on work permits for maintenance and ensure safe opening and closing of the plant on weekends and holidays.</li><li>Approve leave, shift changes, and overtime for production staff while conducting training sessions on production, cGMP, and safety.</li><li>Assist in preparations for ISO/GMP/stock audits and support EHS management systems (ISO 14001, OHSAS 18001) to ensure environmental and safety compliance.</li><li>Maintain cleanliness and housekeeping standards in the plant to ensure an efficient, safe, and compliant work environment.</li></ul>Technical Competencies:Equipment Expertise<ul><li>Sound knowledge of operation of equipment like reactors, centrifuges, dryers, etc.</li><li>Proficient in plant starting and closing procedures.</li></ul>API Manufacturing Process Knowledge<ul><li>Deep understanding of API manufacturing processes, including reaction, distillation, crystallization, filtration, and drying.</li><li>Expertise in unit operations and unit processes necessary for batch processing.</li></ul>Process Monitoring and Control<ul><li>Hands-on expertise with critical process parameters and quality attributes.</li></ul>GMP and Documentation<ul><li>Proficiency in GMP regulations.</li><li>Handling Change control systems, Deviations, and Corrective Action/Preventive Action (CAPA).</li></ul>Validation<ul><li>Operational Qualification (OQ), Performance Qualification (PQ), and Re-Qualification.</li><li>Process and Cleaning Validation: Defining protocols, execution, and report preparation.</li></ul>System Proficiency<ul><li>Skilled in SAP PP module, Distributed Control Systems (DCS), Data Logging Systems (DLS), and MS Office.</li></ul>Safety and Compliance<ul><li>Knowledge of safety protocols, work permit procedures, and PPE matrix.</li><li>Waste classification and adherence to ISO 14001 and ISO 45001 standards.</li><li>Ensuring safety during batch manufacturing and compliance with entry/exit procedures in Zone E areas.</li></ul>Planning and Organization<ul><li>Skilled in scheduling team activities and managing shifts efficiently.</li><li>Keeps track of raw material requirements, process milestones, and reports.</li></ul>Behavioral Competencies:Leadership and Team Management<ul><li>Ability to lead and motivate teams to achieve production goals.</li><li>Promotes teamwork and collaboration among cross-functional teams.</li><li>Manages conflicts effectively to ensure harmony on the shop floor in shifts.</li></ul>Effective Communication<ul><li>Clear and concise communication with team members and cross-functional departments.</li><li>Skilled in conducting shift handovers and ensuring alignment among shifts.</li><li>Ability to communicate technical information to non-technical personnel.</li></ul>Decision-Making and Problem-Solving<ul><li>Makes effective decisions during emergencies or deviations.</li><li>Strong analytical skills for root cause analysis and CAPA implementation.</li><li>Prioritizes tasks and allocates resources effectively.</li></ul>Accountability<ul><li>Takes ownership of production outcomes, including meeting deadlines and ensuring compliance.</li><li>Manages responsibilities with minimal supervision and delivers consistent results.</li></ul>Safety and Quality Orientation<ul><li>Exabits a safety-first mindset and ensures adherence to safety protocols.</li><li>Demonstrates strong commitment to quality and continuous improvement.</li></ul>Conflict Resolution<ul><li>Resolves shop-floor disagreements in a fair and professional manner.</li></ul>Continuous Learning and Improvement<ul><li>Open to feedback and takes initiatives for skill upgrades.</li><li>Encourages team members to adhere to best practices and improve performance.</li></ul> Adherence to Takeda’s Code of Conduct<ul><li>Demonstrates integrity, honesty, and transparency in all activities.</li><li>Ensures ethical decision-making and compliance with Takeda’s values and global guidelines.</li></ul><h2>Locations</h2>Mumbai, India<h2>Worker Type</h2>Employee<h2>Worker Sub-Type</h2>Regular<h2>Time Type</h2>Full time

Senior Officer / Executive - API Manufacturing Plant

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Takeda

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