Job Description

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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

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Mumbai, India

Worker Type

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Employee

Worker Sub-Type

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Regular

Time Type

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Full time