Responsible for ensuring that the appropriate Analytical method validation/Analytical method verification/Analytical method transfer including those of analytical procedures and calibration of equipment are done. Responsible for overall functioning of the quality control department. Responsible for review and updating of specifications for raw material packaging material, finished product and test method to ensure compliance with statutory and company standards. Responsible for monitoring of the manufacturing environment in association with production as a part of quality assurance. Responsible for formal investigation of out of specification laboratory results and documentation of such investigation including action taken. Responsible for investigation of product complaints and reporting of results of such investigation. Responsible for compliance with all statutory requirements including those concerning the labelling of products. Responsible for equipment of the laboratories with adequate glassware, chemical, instruments and personnel to discharge the functions of quality control. Responsible for training of staff in laboratory techniques, general analytical methods quality control procedures and principles of currents good manufacturing practices / General laboratory practices. Responsible for ensuring that all necessary testing is carried out as well as stability studies and quality review. Responsible for approving and monitoring analysis carried out under contract. Responsible for checking the maintenance of the department, premises and equipment. Responsible for ensuring that the required initial and continuing training of quality control personnel is carried out and adapted according to need. Responsible for ensuring that the adequate standards and reagents are maintained. Responsible for ensuring that the records are made manually and/or by recording instruments to demonstrate that all the required sampling, inspection and testing procedure were actually carried out. Any deviation is fully recorded and investigated. Responsible for ensuring that the finished product complies with all legal requirements and is enclosed within its specified container and correctly labelled. Responsible for ensuring that the records which are made of the results of inspection and testing of materials, intermediates, bulk and finished products are formally assessed against specification. Responsible for sufficient reference samples of starting materials and finished products are retained to permit future examination of the product if necessary and the product is retained in its final pack unless exceptionally large packs are produced. Responsible for actual sampling and testing procedures and the actual sampling and testing of starting materials, intermediate products and finished products to verify that they meet the specification before release for further manufacture or sale. It includes online quality control, intermediate and in process controls using production staff while quality control provides technical support and audit. Responsible for inspection, investigation and taking of samples, in order to monitor factors which may affect product quality. Responsible for review of standard operating procedures, instrument operating procedure and equipment operating procedure. Responsible for establishing or approving adequately detailed instructions for carrying out all tests required in connection with the quality control of materials and products. Responsible for establishing procedures for the microbiological testing and microbiological monitoring of materials, products and environment including process water. Responsible for revising the revision of the established quality control specifications and sampling and testing instruction as necessary, replacing superseded versions and maintaining a complete written collection of the current version and an historical record of amendments. The quality control department head/ designee also has responsibilities in the following areas; Validation of critical equipment and procedures.
Responsible for Component Preparation Area and Aseptic Processing Area. Responsible for Packing area activity. Responsible for Visual inspection activity. Responsible for Dispenisng area activity. BMR and BPR preparation, review and compliance. SOP Preparations, review and compliance. Responsible for qualifications like IQ, OQ, PQ and RQ of equipments and facility. Ensure operation and routine activity as per SOP & cGMP norms. Responsible for maintaining the manpower. Coordination with QA, QC, warehouse and engineering for smooth functioning of operations. Handling of QMS activities like deviations, change controls, CAPA and risk assessments. Maintenance and up keeping the area as per cGMP and regulated requirement and putting efforts for improvement in quality and productivity. Responsible for procurement of consumable material required for routine production activity. To ensure schedule validation of the equipment calibration of devices and maintenance of equipment’s.
Manage end-to-end procurement activities for Raw Material, Packing Material, Capital and Engineering and Spares items, ensuring timely delivery and cost-effective sourcing. Conduct market research, vendor evaluation, and negotiation to secure favorable terms and pricing agreements. Develop and implement procurement strategies to optimize supply chain efficiency and reduce lead times. Collaborate with cross-functional teams to align procurement goals with business objectives and maintain inventory levels as per demand forecasts. Monitor supplier performance, resolve issues, and maintain strong relationships with key vendors to ensure quality and reliability. Utilize Excel-data systems and data analytics tools to track procurement metrics, analyze spending patterns, and identify cost-saving opportunities. Assisted in procurement processes including RFQ/RFP, vendor selection, and contract management for various projects. Supported inventory management initiatives to minimize stockouts and optimize inventory turnover ratios. Coordinated logistics and shipping arrangements to ensure timely delivery of materials and equipment.
Responsible for Media preparation, media stock, Media consumption record & Related Documentation. Responsible for Growth promotion test of rehydrated media. Responsible for Daily record of lab and equipment & instrument. Responsible for Daily PH Meter & balance calibration. Responsible for Preparation / Review of SOP, validation protocol & Report etc. Responsible for Environmental monitoring of clean room and other controlled area. Responsible for Water sampling and testing. Responsible for MLT Test of RM, FP, Bulk, Packing material as per pharmacopeia / specification. Responsible for Sterility test, BET Test, media Fill, BIs test as per specification. Responsible for Master sub culturing and record. Responsible for Validation / calibration of lab equipment & instrument. Responsible for Area validation and qualification. Responsible for Validation of autoclave, Incubators & Dry heat sterilizer. Responsible for Online Documentation with respect to GLP, GDP, GMP. Responsible for taking initiative of Change control, OOS, Deviation, CAPA etc. Responsible for keep update and of analyzed reports / Analytical data sheets, formats, log books, records, specifications for raw material, packaging material, finished products and test methods to ensure compliance with statutory and company standards. Responsible for analysis stability analysis and review of documents. Responsible for follow good laboratory Practices. Responsible for ensuring that all necessary testing is carried out as well as stability studies and quality review. Responsible for calibration of instruments / Equipments. Responsible for checking the maintenance of the department, premises and equipment. Responsible for ensuring that the records are made manually and/or by recording instruments to demonstrate that all the required sampling, inspection and testing procedures were actually carried out. Any deviations are fully recorded. Responsible for ensuring that the records which are made of the results of inspection and testing of materials, intermediates, bulk and finished products are formally assessed against specification. Responsible for actual sampling and testing procedures and the actual sampling and testing of starting materials, intermediate products and finished products to verify that they meet the specifications before release for further manufacture. Any other assignment allocated by the Department head or designee.
1. To understand, implement and follow monthly production schedule. 2. To set, operate and clean different packing equipment like Blister pack m/c like IMA PG excel plus (Platen type), Cartoning machine, HDPE bottle packaging, defoiling m/c, overprinting m/c, etc. as per SOP and document the same. 3. To ensure that machine changeover is done with minimum/ optimum time. 4. Check and document various m/c setting parameters as per BPR. 5. Carry out various in process checks as per BPR and document the same. 6. To carry out Cleaning of the equipments and area as per the requirement and document the same. 7. To check and record various parameters of environmental conditions of the room. 8. To have a control on rejections generated during m/c setting and operation. 9. To ensure that status labeling is done as per QAP/ SOP/ BPR. 10. To check and record qty. of excess primary packing material returned to stores. 11. To ensure that rejections moved out from blister room is free from tablets. 12. To report to Packing officer/ Executive for requirement of m/c spares, and consumable items required for smooth operation of machine. 13. To ensure that Packing machine change parts are segregated, identified and stored properly in their respective storage areas. 14. To maintain cleanliness and hygiene at place work. 15. To maintain safety of product, self and machine at work place. 16. To maintain Good conduct and discipline in the department and in the premises. 17. To assist in carrying out qualification of new equipments, process validation and documentation of same. 18. To coordinate with maintenance department to get the equipment defect rectified, missing parts replaced and keep all the equipments in good running condition at all the times. 19. To prevent and control any damage to doors, windows, cupboards, floor, ceiling, and any other part of the facility, internally as well as externally. 20. To report any deviation, untoward incident, accident to the superior. 21. To ensure that product manufactured is of quality as specified. 22. To have an active participation during audits.
1. To understand, implement and follow monthly production schedule. 2. To set, operate and clean compression machine Cadmach C-300 and different equipments as per respective SOP and document the same. 3. To ensure that machine spares, punches & dies are segregated, identified and stored properly in their respective storage areas. 4. To maintain and record of punch inspection as per SOP. 5. To ensure that daily/ monthly production target is achieved. 6. To ensure that machine changeover is done with minimum/ optimum time. 7. Check and document various m/c setting parameters as per batch record. 8. Carry out various in process checks as per batch record and document the same. 9. To carry out Complete cleaning and General cleaning of the m/c and area as per the requirement and document the same. 10. To check and record various parameters of environmental conditions of the room. 11. To have a control on rejections generated during m/c setting and operation. 12. To ensure that status labeling is done as per SOP/ Batch record. 13. To document and maintain the necessary logs as per procedure. 14. To report to Production officer/ Executive for requirement of m/c spares, and consumable items required for smooth operation of machine. 15. To maintain stock of required consuambles. 16. To maintain cleanliness and hygiene at place work. 17. To maintain safety of product, self and machine at work place. 18. To ensure that proper attire and dress code is followed in the department. 19. To maintain Good conduct and discipline in the department and in the premises. 20. To assist in carrying out qualification of new equipments and documentation of same. 21. To coordinate with maintenance department to get the equipment defect rectified, missing parts replaced and keep all the equipments in good running condition at all the times. 22. To prevent and control any damage to doors, windows, cupboards, floor, ceiling, and any other part of the facility, internally as well as externally. 23. To report any deviation, untoward incident, accident to the superior. 24. To ensure that product manufactured is of quality as specified. To have an active participation during audits.
1. To understand, implement and follow monthly production schedule. 2. To set, operate and clean RMG/FBE/OGB and different mfg equipments as per SOP and document the same. 3. To ensure that daily/ monthly production target is achieved. 4. To ensure that machine changeover is done with minimum/ optimum time. 5. Check and document various m/c setting parameters as per batch record. 6. Carry out various in process checks as per batch record and document the same. 7. To carry out Complete cleaning and General cleaning of the m/c and area as per the requirement and document the same. 8. To check and record various parameters of environmental conditions of the room. 9. To have a control on rejections generated during m/c setting and operation. 10. To ensure that status labeling is done as per SOP/ batch record.. 11. To document and maintain the necessary logs as per procedure. 12. To report to Production officer/ Executive for requirement of m/c spares, and consumable items required for smooth operation of machine. 13. To ensure that Sieves and screens, FBD bags, etc are segregated, identified and stored properly in their respective storage areas. 14. To maintain cleanliness and hygiene at place work. 15. To maintain safety of product, self and machine at work place. 16. To ensure that proper attire and dress code is followed in the department. 17. To maintain Good conduct and discipline in the department and in the premises. 18. To assist in carrying out qualification of new equipments and documentation of same. 19. To coordinate with maintenance department to get the equipment defect rectified, missing parts replaced and keep all the equipments in good running condition at all the times. 20. To prevent and control any damage to doors, windows, cupboards, floor, ceiling, and any other part of the facility, internally as well as externally. 21. To carry out training and guidance to new production operators. 22. To report any deviation, untoward incident, accident to the superior. 23. To ensure that product manufactured is of quality as specified. To have an active participation during audits.
Primary responsibility: 1- To Review executed BMR and BPR. 2- Responsible for Line clearance of GOSD & HINJ. 3- To handle PQR (Product Quality Review) activity. 4- To handle Hold time study 5- To review & approval of master BMR and BPR. To handle any work allocated by HOD-QA as and when required
Responsible for Disinfectant preparation and filtration as per schedule. Cleaning and operation of Manufacturing Vessel and Filtraion vessel. Responsible for Batch Manufacturing anf filtration Activity. Responsible for Dispenisng area activity. Area cleaning and fogging as per standard operating procedure. Maintaining and keeping the area as per cGMP and regulated requirement. Cleaning and operation of ampoule and vial washing machine and Tunnel. Cleaning and operation of steam sterilizer. Cleaning and operation of isolator. Cleaning and Operation of Offline Non-Viable Particle Counter. Cleaning and Operation of Dynamic and static Pass Box, Ceiling Suspended LAF. Cleaning and Operation of Glove Integrity Testing Machine. Responsible for filter integrity of filter.
Develop and maintain cost accounting systems, policies, and procedures to ensure accurate and timely financial reporting. Monitor and analyze manufacturing costs and financial performance against budget, forecat, and actual results. Prepare monthly and quarterly financial reports and variance analysis. Conduct financial analyses on capital expenditures, costsaving initiatives, and other business projects. Develop and implement cost accounting methodologies, including standard costing and activity based costing. Collaborate with crossfunctional teams to identify and implement costsaving opportunities. Assist in the preparation of annual budgets and monthly forecasts. Ensure compliance with accounting standards and regulatory requirements. Continuously monitor and improve accounting processes and systems to streamline and enhance the accuracy and efficiency of financial reporting. Product Costing of Tablets, Capsules, Ampoules and Vials etc. In-depth analysis of Raw Material and Packing Material cost and Highlighting API Contribution in Product Plant wise Variance Analysis, Focused on Production, Sale Output and Consumption By applying Standard Costing and ensure Production is as per BOM, Calculation of Wastage Batch wise Contribution Report and highlight to management for Profit and Loss making products in separate batches Overhead allocation calculation Assist BD team and Management in Finalization of Price
Developing and validating analytical test methods for the testing of pharmaceutical products for ICH requirements. Solving complex analytical problems. Ensuring Good Lab Practices to be followed in the QC lab To ensure that all the necessary sampling, testing and calibration is carried out as per the approved specifications and SOPs. Transferring new analytical techniques to the Quality Control (QC) laboratory. Validating and maintaining equipment for analytical development activities. Controlling laboratory chemicals required for analytical development activities Writing/reviewing specifications and methods of analysis for API, excipients, Packing materials, in-process and finished Products. Responsible for review the records and documents and archival of projects records Calibrate the instruments according to the master calibration schedule and follow GLP and follow SOPs and STP. Participating in self-inspections and regulatory inspections. Coordinate with supervisor to complete the Projects within timelines. Using laboratory chemicals in accordance with Health and Safety and in-House requirements.
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