Senior Officer / Executive - API Manufacturing Plant

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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.

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