1. Job Role & Responsibilities

1. Knowledge of pharmaceutical production activities, including formulation development, scale-up, and technology transfer.
2. Preparation, review, and maintenance of cGMP documentation, including Batch Manufacturing Records (BMR), Batch Production Records (BPR), SOPs, change controls, and other relevant production documents.
3. Knowledge and adherence to current Good Manufacturing Practices (cGMP), Positive Documentation Practices (GDP), and applicable regulatory requirements.
4. Hands-on knowledge of manufacturing equipment used in cGMP-controlled areas for Solid Oral Dosage Forms (SODF) and Liquid Oral Dosage Forms (LODF).
5. Execution of production and development batches as per approved batch records, protocols, and SOPs.
6. Knowledge of equipment operation, cleaning, line clearance, and production area readiness.
7. Coordination with QA, QC, Engineering, Warehouse, and Formulation Development teams for smooth execution of production activities.
8. Compliance with safety procedures for handling oncology products, including appropriate PPE, containment, and decontamination practices.
9. Maintenance of equipment logbooks,



batch records, and other relevant production documentation.
10. Support in deviation reporting, investigation, CAPA, change control, and technology transfer activities, as applicable.

Candidate Profile

1. 15 years of experience in pharmaceutical production, preferably in oncology formulation manufacturing or development.
2. Knowledge of production processes for Solid Oral Dosage Forms and Liquid Oral Dosage Forms.
3. Understanding of cGMP, GDP, and pharmaceutical documentation practices.
4. Familiarity with production equipment used in controlled manufacturing areas.
5. Basic computer knowledge, including MS Word, MS Excel, and electronic documentation systems, where applicable.
6. Good communication, documentation, and coordination skills.
7. Knowledge of oncology product handling and applicable safety requirements will be preferred.
8. Preferred Candidate: A candidate with hands-on experience in oncology production, formulation development, cGMP documentation, and technology transfer activities.

📌 Production Officer (Navi Mumbai)
🏢 Fusion Scientific Laboratories
📍 Navi Mumbai