Monitoring and Inspection: Real-time Process Monitoring: Observing all stages of production (dispensing, granulation, compression, coating, filling, packaging, etc.) to ensure strict adherence to documented Standard Operating Procedures (SOPs) and GMP guidelines. Line Clearance Activities: Performing thorough checks and providing approval (line clearance) before the start of any new product, batch, or process changeover to prevent mix-ups and cross-contamination. In-Process Checks (IPC): Conducting or verifying in-process quality control tests and parameters, such as tablet weight variation, hardness, friability, disintegration time, pH, and viscosity, as specified in the Batch Manufacturing Record (BMR). Environmental Monitoring: Monitoring and documenting critical environmental conditions like temperature, humidity, and differential pressure in cleanroom and manufacturing areas. Process Validation: During process validation providing documented evidence that, manufacturing process consistently yields a product of predetermined quality. Equipment Status Verification: Ensuring that all equipment, instruments, and systems are properly calibrated, validated, and have the correct "clean" or "in use" status labels. Documentation and Compliance: Batch Record Review: Reviewing and verifying Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs) in real-time or after completion to ensure all entries are accurate, complete, and signed off as per GMP requirements. SOP Management: Controlling the issuance, retrieval, and adherence to SOPs, BMRs, and other quality documentation. Deviation and Non-Conformity Handling: Identifying, reporting, and documenting any deviations or non-conformities from approved procedures. They often assist in the investigation (root cause analysis) and the implementation of Corrective and Preventive Actions (CAPA). Audit Readiness: Ensuring that their assigned production areas are continuously compliant and ready for internal audits, self-inspections, and external regulatory inspections (e.g., WHO, ISO). Collaboration and Training: Cross-functional Collaboration: Working closely with the Production, Quality Control (QC), and Research and Development (R&D) teams to resolve quality issues and promote continuous improvement initiatives. Training Staff: Training and mentoring production and packaging staff on quality procedures, GMP, and data integrity practices. Job Types: Full-time, Permanent Pay: ₹30,675.28 - ₹34,785.39 per month Benefits: Leave encashment Paid sick time Provident Fund Application Question(s): What is your highest Qualification? Education: Bachelor's (Preferred) Experience: Tablet manufacturing: 5 years (Required) Language: Bengali, Hindi & English (Preferred) License/Certification: CTS for Pharmaceutical Production (Required) Location: New Town, Kolkata, West Bengal (Preferred) Shift availability: Day Shift (Preferred) Work Location: In person