Emil Pharmaceutical

Role & responsibilities 1. Quality Control Operations Supervise and perform analysis of in-process and finished pharmaceutical products as per pharmacopeial methods (IP, BP, USP, EP). Ensure timely sampling and testing of batches during manufacturing and post-production. Monitor compliance with Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP) . Conduct HPLC, GC, UV, IR, KF, Dissolution, and other instrumental testing . Maintain and calibrate laboratory equipment. 2. Documentation & Review Review and approve analytical reports, CoAs, and logbooks. Ensure proper documentation of results in LIMS or paper-based systems as per ALCOA+ principles. Investigate OOS, OOT, and deviations related to finished products and in-process samples. 3. Compliance & Regulatory Support regulatory inspections (USFDA, MHRA, WHO, etc.) and customer audits. Maintain readiness of QC labs as per regulatory requirements. Participate in internal and external audits and implement CAPAs. 4. Team Management & Training Supervise QC analysts and ensure task allocation and training. Develop SOPs, and provide on-the-job training to the QC team. Coordinate with QA, Production, and Warehouse teams for smooth QC operations.

Oversee the daily operations of the packaging department, ensuring the timely and efficient packing of pharmaceutical products. Supervise and guide the packing team to ensure adherence to production schedules. Ensure the packing area is organized, clean, and compliant with GMP (Good Manufacturing Practice) guidelines. Coordinate with other departments like Quality Control, Supply Chain, and Production to align on daily targets and deliveries. Ensure that the packaging process adheres to all GMP, GLP (Good Laboratory Practice), and regulatory requirements (FDA, WHO, etc.). Monitor and ensure that proper documentation is maintained for each batch (batch records, labeling, and packaging). Conduct in-process checks to ensure that the packing is done in accordance with the standard operating procedures (SOPs). Oversee the operation and maintenance of packing equipment and machinery. Ensure that packing machines are calibrated and maintained properly. Coordinate with maintenance staff for the timely servicing and repair of equipment. Monitor and maintain the efficiency of packing lines and troubleshoot any issues that may arise during production. Identify areas of improvement in the packing process to enhance productivity. Assist in implementing continuous improvement projects to optimize packing operations. Maintain adequate inventory levels of packing materials (bottles, cartons, labels, etc.). Work with the supply chain department to ensure smooth availability of materials and resolve any shortages or delays.

Operate and monitor packing machinery for dry powder pharmaceuticals. Ensure that powder is packed in correct quantities, weights, and packaging specifications. Perform routine checks to maintain machinery in optimal working condition. Verify packaging materials, labels, and batch records to ensure compliance with regulatory and quality standards. Perform in-process inspections and checks to ensure proper filling, sealing, and labeling. Report any deviations or discrepancies to the supervisor and take corrective actions. Follow all GMP guidelines and maintain a clean and safe working environment. Ensure compliance with SOPs (Standard Operating Procedures) and regulatory requirements. Maintain proper documentation for all packing activities and related records. Work closely with production, quality control, and warehouse teams to ensure timely production schedules are met. Assist with training new staff on packing procedures and equipment. Participate in ongoing training to improve packing processes and stay current with industry best practices. Identify opportunities for process optimization and work with management to implement improvements.

Supervise day-to-day operations of the external preparation manufacturing section. Ensure proper execution of batch manufacturing processes as per Batch Manufacturing Records (BMRs) and Standard Operating Procedures (SOPs). Coordinate with Quality Assurance (QA), Quality Control (QC), Warehouse, and Maintenance for smooth operations. Monitor equipment calibration, cleaning, and maintenance to ensure readiness for production. Ensure proper line clearance, area cleaning, and equipment readiness before starting manufacturing operations. Review and maintain manufacturing documentation, including BMRs, logbooks, and deviation reports. Handle in-process checks and ensure process parameters are maintained within specified limits. Train and guide operators and junior staff in GMP practices and SOP adherence. Investigate deviations and support in root cause analysis and implementation of CAPA. Ensure compliance with EHS (Environment, Health, and Safety) standards within the manufacturing area.

Supervise day-to-day operations of Dry Powder Filling, Mixing, and Packing activities. Ensure batch manufacturing records (BMR) and other documentation are filled accurately and in a timely manner. Ensure cleanroom discipline and maintain the required environmental conditions in the production area. Coordinate with QA, QC, Maintenance, and Warehouse departments for uninterrupted production. Follow and enforce adherence to Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP). Perform and supervise line clearance, cleaning, and sterilization procedures for equipment and areas. Maintain production logs, equipment usage logs, and cleaning records . Participate in investigations (deviations, incidents, and OOS) and implement corrective/preventive actions. Train new operators and assistants in processes and GMP standards. Monitor and report on yield, wastage, and productivity metrics. Ensure compliance with regulatory and safety requirements (USFDA, MHRA, WHO, EHS, etc.).

Operate and monitor compression machines (e.g., Cadmach - ACC). Ensure smooth execution of batch production as per BMR/BPR and SOPs. Carry out in-process checks (IPC) like weight variation, hardness, thickness, friability, etc. Perform machine changeovers, cleaning, and line clearance. Maintain and update Batch Manufacturing Records (BMRs), logbooks, equipment usage logs. Adhere strictly to cGMP, GDP, and safety norms. Participate in audits (internal/external) and handle compliance requirements. Collaborate with QA, maintenance, and validation teams. Report deviations, breakdowns, and implement corrective/preventive actions (CAPA). Suggest and implement process improvements for yield and productivity.

Execute daily coating production activities as per batch production records (BPRs). Supervise the mixing, blending, and application processes for various coating formulations. Ensure proper setup and maintenance of coating equipment (e.g., mixers, spray booths, curing ovens). Monitor in-process parameters and adjust formulations or processes to maintain product quality. Ensure compliance with ISO, GMP, and EHS guidelines. Coordinate with QC and R&D teams for sampling, trials, and product validation Maintain accurate production records, logs, and shift reports. Assist in preparing Standard Operating Procedures (SOPs) and work instructions. Report deviations, rejections, and ensure corrective actions are taken. Monitor raw material usage, stock levels, and report shortages. Ensure timely requisition and transfer of materials from the store to production.

Monitor day-to-day operations to ensure adherence to GMP guidelines. Conduct routine inspections and walkthroughs on the shop floor. Identify non-compliance areas and coordinate corrective/preventive actions (CAPA). Review and update Standard Operating Procedures (SOPs), batch records, and other GMP-related documentation. Ensure proper documentation practices (GDP) are followed across departments. Assist in internal audits and regulatory inspections (e.g., FDA, MHRA, WHO, TGA). Coordinate audit responses and track closure of observations. Organize and conduct GMP training for staff at all levels. Promote a quality culture through awareness programs and initiatives. Participate in risk assessments and deviation investigations. Ensure timely reporting and escalation of critical quality issues. Recommend and implement process improvements related to GMP compliance. Support cross-functional teams in quality initiatives and validation activities.

Oversee line clearance , in-process sampling, and real-time review of batch manufacturing & packaging records (BMR/BPR) Monitor critical process parameters (e.g., weight variation, leak tests), hygiene, documentation, calibration, and equipment qualification Lead investigations for deviations, OOS/OOT results, non-conformities; drive CAPA and root cause analysis Approve/reject batches, handle change-controls and disposals, and manage legal/retention samples Support and participate in internal, external, and regulatory audits/inspections ; ensure audit readiness Prepare, review, and maintain SOPs, protocols (validation, cleaning, process), quality documentation, and MIS reporting

Monitor all in-process manufacturing and packaging activities on the shop floor. Perform line clearance before manufacturing/packaging starts. Verify batch records and ensure adherence to SOPs and BMR/BPR entries. Check critical control points and parameters during manufacturing. Review batch manufacturing records (BMR), batch packaging records (BPR), and logbooks in real time. Ensure timely and accurate documentation of in-process observations. Escalate any deviation or non-conformance observed during the process. Ensure compliance with cGMP, GDP, and regulatory requirements. Assist in handling deviations, change controls, and CAPAs. Participate in internal audits and regulatory inspections. Verify the status and calibration of equipment before use. Ensure proper labeling, handling, and storage of materials.

Review and approve validation protocols (IQ/OQ/PQ), reports, and related documentation for manufacturing equipment, utilities, and processes. Provide QA oversight during the planning and execution of process validation and cleaning validation activities. Ensure all validation activities are conducted in accordance with current Good Manufacturing Practices (cGMPs), company policies, and industry standards. Participate in risk assessments (e.g., FMEA) to support validation strategy development. Support investigations and change controls related to validated systems or processes. Collaborate with Manufacturing, Engineering, QC, and Regulatory Affairs to ensure validation deliverables are aligned with product quality requirements. Maintain validation documentation and ensure data integrity in all QA records. Conduct QA review and approval of protocols and reports for re-validation and periodic reviews. Support internal and external audits and inspections, providing SME support for validation topics.

Monitor compliance with GLP, GMP or other applicable standards. Maintain and update SOPs (Standard Operating Procedures). Review laboratory notebooks, worksheets, and analytical reports. Assist in internal and external audits. Ensure accurate documentation of QA activities and laboratory testing. Review COAs (Certificates of Analysis) and batch records. Manage deviation reports, CAPAs, and change control processes. Assist in the qualification/validation of equipment, methods, and software. Ensure timely calibration and maintenance of lab instruments.

Supervise and coordinate QA lab personnel and activities related to sampling, testing, and reporting of raw materials, in-process samples, and finished products. Ensure compliance with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and regulatory guidelines (e.g., FDA, ISO, ICH, etc.). Review and approve analytical test results, COAs (Certificates of Analysis), and related documentation. Manage calibration, maintenance, and validation of laboratory instruments (e.g., HPLC, GC, UV-Vis, FTIR). Investigate out-of-specification (OOS), out-of-trend (OOT), and non-conformances; participate in root cause analysis and CAPA implementation. Ensure timely completion of stability studies and trending of data.

Maintain control of documents such as SOPs, work instructions, forms, policies, and records. Ensure documents are reviewed, approved, updated, and archived per document control procedures. Maintain the Document Control Register and Master List of Documents. Assist in the preparation of quality manuals, procedures, and other QMS documentation. Support the implementation and maintenance of ISO 9001 (or other applicable QMS standards). Assist in internal audits, including audit preparation, scheduling, and tracking corrective/preventive actions (CAPA). Monitor and report QMS performance through KPIs, nonconformance records, and continuous improvement initiatives. Coordinate Management Review Meetings and maintain related documentation. Ensure adherence to regulatory, statutory, and customer-specific quality requirements. Participate in external audits (e.g., certification audits, customer audits). Help prepare documentation for regulatory submissions or inspections as required. Maintain records related to quality objectives, customer complaints, NCRs, and audit findings. Generate reports on QMS performance, deviations, and document revisions. Ensure traceability and version control of all critical documents.

Receive, inspect, and verify all incoming pharmaceutical stock. Ensure proper storage conditions (temperature, humidity, segregation) as per regulatory and product requirements. Perform regular inventory checks, cycle counts, and stock reconciliation. Maintain accurate inventory records using WMS/ERP systems. Pick, pack, and dispatch pharmaceutical orders in a timely and accurate manner. Ensure proper labeling and documentation (batch number, expiry dates, etc.) for all outgoing shipments. Coordinate with logistics providers for timely deliveries. Ensure compliance with GDP, GMP, and other relevant regulatory guidelines. Maintain cleanliness and orderliness of the warehouse as per SOPs. Handle near-expiry, damaged, or recalled products in accordance with company policy. Maintain complete and accurate records for all warehouse transactions. Prepare and submit periodic stock reports, damage reports, and discrepancy reports. Assist in audits and inspections (internal/external).

Carry out manufacturing activities as per Batch Manufacturing Records (BMR) and SOPs. Monitor and control production parameters to meet quality and output targets. Ensure timely completion of batches to meet production schedules. Ensure adherence to current Good Manufacturing Practices (cGMP) and company policies. Report and document any deviations, incidents, or abnormalities during production. Operate, clean, and maintain manufacturing equipment (e.g., granulators, blenders, tablet compression machines, filling machines). Perform line clearance, changeovers, and cleaning as per SOPs. Maintain accurate and timely records of all production activities. Fill out logbooks, checklists, and BMRs/BPRs (Batch Production Records) as per regulatory standards. Coordinate with QA, QC, maintenance, and warehouse departments to ensure smooth workflow. Support validation activities, including equipment qualification and process validation.

Perform routine maintenance and troubleshooting of electrical systems and machinery in the pharmaceutical manufacturing plant. Maintain and repair motors, control panels, UPS, HVAC systems, and other electrical components. Ensure electrical safety as per GMP, GEP, and EHS guidelines. Assist in installation and commissioning of new equipment. Maintain accurate documentation of electrical maintenance work and breakdown records. Work in compliance with SOPs, GMP, and company safety policies. Coordinate with the production team to minimize downtime. Conduct preventive and predictive maintenance as per schedule. Support in energy conservation and improvement initiatives.

Perform preventive, predictive, and breakdown maintenance of pharmaceutical equipment (e.g., tablet presses, blister packing, autoclaves, HVAC systems). Diagnose and troubleshoot mechanical, electrical, and utility issues promptly. Support calibration of instruments and equipment as per schedule. Assist in qualification and validation activities (IQ/OQ/PQ) for new or modified equipment. Maintain all maintenance records, logs, and calibration reports as per GMP and SOP requirements. Ensure compliance with regulatory norms (USFDA, MHRA, WHO-GMP, etc.). Operate and maintain critical utilities such as HVAC, water systems (RO, WFI, PW), steam boilers, compressors, and DG sets. Monitor utility parameters and take corrective actions if deviations occur. Participate in root cause analysis and implement corrective and preventive actions (CAPA). Support initiatives for energy conservation and efficiency improvement.

Execute preventive, predictive, and breakdown maintenance of production and utility equipment (e.g., HVAC, AHU, air compressors, chillers, boilers, WFI/RO systems, etc.). Troubleshoot mechanical, electrical, and instrumentation issues to minimize downtime. Prepare and maintain SOPs, maintenance logs, calibration records, and equipment qualification documents (IQ, OQ, PQ). Ensure compliance with cGMP, GDP, and safety standards. Participate in internal and external audits (e.g., USFDA, MHRA, WHO, etc.). Support installation and commissioning of new equipment and utilities. Assist in engineering change controls, validations, and equipment upgradation. Monitor energy consumption and suggest improvements for utility efficiency. Implement engineering best practices to reduce downtime and maintenance costs

Plan and execute preventive maintenance schedules for critical equipment (HVAC, AHUs, boilers, chillers, WFI, RO systems, autoclaves, etc.). Troubleshoot and resolve breakdowns in coordination with cross-functional teams. Support IQ/OQ/PQ of new and existing equipment. Ensure timely calibration of instruments as per the calibration schedule. Monitor and manage the operation of utilities such as purified water systems, HVAC systems, compressed air, and electrical systems. Maintain utility logbooks and ensure adherence to SOPs and GMP norms. Maintain engineering documents like machine history cards, maintenance logs, and calibration records. Ensure compliance with cGMP, FDA, WHO, and other regulatory guidelines. Assist in new equipment installation and facility modifications. Coordinate with vendors and contractors for engineering projects.