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