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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