1. Production Formulation - (Granulation/Compression/Coating)
- Machine Operation: Set up and operate OSD machinery such as RMG, FBD, Blenders, Compression machines (e.g., Fette, Korsch), and Auto-coaters.
- In-Process Checks: Conduct regular checks for tablet weight, thickness, hardness, and friability during compression.
- Material Handling: Accurately weigh and mix raw materials as per the Batch Manufacturing Record (BMR).
- Line Clearance: Perform thorough cleaning of equipment and work areas to ensure zero cross-contamination before starting new batches.
2. Packing Operations (Primary & Secondary)
- Packing Line Operation: Operate and monitor automated Blister, Strip, and Bottle packing machines.
- Labeling & Coding: Ensure accurate batch coding, overprinting, and labeling of finished goods according to market specifications.
- Quality Inspection: Visually inspect final packages for seal integrity, empty pockets, or printing defects.
- Yield Reconciliation: Assist in the reconciliation of packing materials (foils, cartons, labels) at the end of each batch.
3. QC Analyst HPLC / Instrumentation - Analytical Testing & Operations
- HPLC Analysis: Conduct routine and non-routine analysis of Raw Materials (RM), Finished Products (FP), and Stability samples using HPLC.
- Testing Scope: Perform critical tests including Assay, Dissolution, Content Uniformity (CU), and Related Substances (RS).
- Method Performance: Execute system suitability tests, peak integration, and pureness analysis to ensure reliable data.
- Sample Preparation: Accurately prepare standard/sample solutions, mobile phases, and reagents as per Standard Test Procedures (STP).
Compliance & Documentation
- Data Integrity: Record all raw data, observations, and calculations in real-time according to ALCOA+ principles.
- OOS Investigations: Identify and immediately report Out-of-Specification (OOS) or Out-of-Trend (OOT) results; support root cause investigations.
- Regulatory Standards: Maintain strict adherence to cGMP, GLP, and 21 CFR Part 11 requirements.
Instrument Maintenance
- Calibration: Perform daily verification and periodic calibration of HPLC systems (e.g., Waters, Agilent, Shimadzu).
- Troubleshooting: Diagnose and resolve minor instrument or method-related issues to minimize laboratory downtime
4. Quality Assurance (QA / IPQA)
- Oversee QMS elements, including the handling and closure of Deviations, Change Controls, and CAPAs.
- Perform In-Process Quality Assurance (IPQA) monitoring during manufacturing and packing stages.
- Review executed Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) prior to product release.
- Conduct internal audits and lead preparation for external regulatory inspections (USFDA, MHRA, EMA).
- Manage document control, including the preparation and review of SOPs and Master Formula Cards.
5. Engineering role (Fresher to 3 years experience) focusing on Civil, HVAC, and Pharmaceutical Machinery
- Machine Maintenance & Troubleshooting: Execute preventive and breakdown maintenance on specialized process equipment including Granulation, Coating, and Compression machines to ensure zero downtime.
- HVAC & Environmental Control: Monitor and maintain HVAC systems (AHUs, Chillers) to ensure cleanroom parameters like temperature, humidity, and pressure comply with 2026 cGMP and ISO standards.
- Civil & Facility Management: Supervise structural repairs, floor epoxy maintenance, and plumbing works while coordinating with contractors for site upgrades and Bill of Quantities (BOQ).
- Compliance & Documentation: Prepare and update rigorous technical logs, SOPs, and validation documents (IQ/OQ/PQ) as required by international regulatory audits like the USFDA.
- Utility & Safety Optimization: Monitor utility consumption and implement safety protocols (LOTO) to ensure all mechanical and civil operations meet current workplace safety and energy efficiency targets.