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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.

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