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** **"Join Our Team" at Zydus Takeda Healthcare Private Limited at Navi Mumbai** **_At Zydus Takeda, excellence drives us, and innovation inspires us. Be part of a dynamic environment where your expertise ensures seamless operations and your passion makes a difference in transforming lives. Step into a rewarding career and contribute to delivering life-changing healthcare! 🚀_** **Hiring for Assistant Manager/ Sr. Executive - API Mfg. Plant** **Qualification** **: B.E / B.Tech - Chemical Engineering preferably from reputed institutes** **4-6 Years of experience in API Manufacturing** **Qualification** : B.E./ B Tech (Chemical Engineering) **Experience** : Minimum 10 to 12 years in API manufacturing Plant **Responsibilities: -** + Plan for the Availability of raw material and other accessories needed for processing as per the Rolling Production Forecast. + Plan the manufacturing activities as per the raw material, manpower, equipment availability. + Identifying and controlling the process parameters as mentioned in the BMR considering various aspects like process safety process requirements. + Ensure that proper PPEs are made available to Shop floor personnel. + Achieving Target production, meeting the quality standards laid down, complying with all safety standards. + To review new SOP, BMR, BPR, FSIR, ECR and all manufacturing related documents. + Conducts training sessions on Current Good Manufacturing Practices (cGMP) and Standard Operating Procedure (SOP) and general shop floor safety for officers and below cadre. + Updating cGMP and ISO related documents. Preparing for and facing different types of regulatory audits. + Ensure Environment protection by controlling Air/Water/Soil pollution from manufacturing activities. + To assist in departmental activities related to the EHS management system (ISO 14001-2015 and ISO 45001-2018). + Accountable for the safe operation of the facility, their own safety and safety of other co-workers. + To coordinate with Quality assurance, Quality control, Engineering, Safety and Stores to ensure smooth functioning of the department. + To conduct internal Audits related to cGMP/ISO. + Being updated with the beginning and closing of the plant with the Manager. + Coordinating with the Head Manufacturing with regards to performance appraisal of Officer and below cadre and any other matter related to the employee. + Provide assistance in preparing manufacturing and dispatch schedule. + Discussing with the various vendors and consultants about the various requirements of process and its other accessories. + To raise change control, deviation in TrackWise as and when required in co-ordination with plant in charge. + To ensure all SAP transactions related to manufacturing are online and completed. + To suggest ways and means to reduce time cycles and ways to reduce energy consumption in coordination with Manufacturing Sciences and Engineering Departments. **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