JOB DESCRIPTION: Perform calibration of analytical instruments and online documentation as per GDP requirements. Work as per Good Laboratory Practices. Maintaining log books, Column usage cards and calibration records . Report preparation.
Job Responsibilities : 1. Coordinate and drive activities under guidance of Group Leader/ Head Of Department. 2. Conduct Literature survey of assigned projects. 3. Plan 7 Execute experiments as instructed and discussed. 4. Discuss reaction observations with GL/HOD 5. Records Experiments in the Laboratory note book as per SOP, update and get checked by seniors. 6. Follow up for analysis and collect analytical reports from ADL, interpret the results. 7. Record analyses results like chromatograms, chemical analysis etc. in the lab note book. 8.Maintain experimental and analysis reports. 9. Evaluate costing of the product to achieve target RMC 10. Support to QA and RA for necessary documentation and queries. Following are some of the Job Responsibilities.
Job Role : Analyst - Microbiology Job Description : 1. To Follow Good Laboratory Practices as Laid Down In quality Control Standard operating procedures. 2. carry out calibration of the instruments in Microbiological department. 3. Daily Monitoring of Pressure Differentials, Temperature- Humidity of Microbiological Laboratory Rooms and Equipment's. 4. Microbiological Analysis of purified water, potable water and finished product. 5. Environmental monitoring of MF2, MF3, MF4, store and Microbiological Department. 6. Sterilization and destruction of media. 7. analysis of purified water for TOC content. 8. Daily data downloading of incubators.
Role & responsibilities General Administration - Guest Management /Audit Management - Canteen Management - Laundry Management - Visitor Management - Transport Management Contract Labour Management: - Cordinating with respective Dept. Head and Manpower Supplier to finalised requirement monthly and ensure same is fulfilled. - Monthly checking of Contractor bill and payment along with statutory compliances and ensure wages are paid within on or before 7 th day of respective month Monthly purchase requisition and Admin Bill processing in SAP - Generating PR in SAP Ensure all request for Purchase are done in SAP and requirements are fulfilled within time line - 'Service entry of Admin Bills All payment to vendors are done with 07 days from receive invoice Security Management - Ensure 100% Compliance and Vigilance in Man & material movement - Reconciliation of inward, outward and returnable/ non-returnable material - Deployment of Security Personnel as per sanction strength
Role & responsibilities 1. Routine and Stability analysis of development batches. 2. Analytical support for development of new or existing APIs. 3.Analytical method development and validation of raw materials, intermediates, finished APIs, under close supervision of senior analyst. 4.Qualification, Calibration and maintenance of analytical instruments. 5.Perform Calibration of analytical instruments and online documentation as per GDP requirement. 6. Preparation / Review of test method specification, method development protocol, method development report and analytical reports. 7. Work as per Good Laboratory Practices (GLP). 8. Maintaining log books, column usage cards and calibration records. 9. Following safety in the laboratory premises by using personal protective equipment and guiding to the subordinates to follow safety norms.
Role & responsibilities Preferred candidate profile
1. Carry out all operation as per SOP, BMR. 2. Carry out all processes as per BMR, ECR & daily logs. 3. Complete the BMR, ECR, log books, daily records and ensure that are completed & signed. 4. Keep production facility clean and appropriate disinfected. 5. Maintain all equipment and surrounding area cleaned while batch processing to avoid Contamination. 6. Carry out daily weight verification of Weighing Balances as per SOP. 7. Cleaning of all Equipments as per the ECRs and SOP’s. 8. Execute all production activities as per instruction of superiors viz, Drum handling, Material handling, Raw material charging, Loading & Unloading the material, Milling, Sifting activity, etc. 9. Follow EHS norms like using PPE, earthing and bonding, material handling, MSDS etc 10. Should handle the equipment Reactor, Centrifuge, Dryer , Filter
Preparation of DMF/ASMF in compliance with regulatory standards, country specific guidelines and procedures. Experience in handling API drug submissions to regulated markets Canada, UK, Europe, Brazil, China, Japan, US etc. Filing amendments, updates with relevant health agencies Knowledge and experience in handling submission of documentation to regulatory agency via e-CTD software Preparation of response to queries received from health authorities and customers Evaluation of regulatory impact and review of QMS documentation Coordination with various stake holders at site for documentation Participation in project review meeting regarding new products and providing regulatory feedback Licensing Activities: Interaction with Licensing authorities Monitor and maintain all valid licenses as per Drug and Cosmetic act. 1940 and Rules 45. Applications for new licences according to requirements. Online applications on NSWS/ SUGAM portal. Monitor and maintain all documents as per NDPS act. 1985. Monitor and maintain Legatrix activities Monitor and maintain Loan Licenses certificate and approvals.
Role & responsibilities Working in shift (First shift, second shift & night shift). 2. In case of reliever absent continuous the next shift. 3. Received maintenance job requisition in all plant & departments & take immediate action. 4. After completion of Job, completed the job requisition with sign. 5. Carrying out the preventive maintenance activity as per instruction of his supervisor & seniors. 6. Attending breakdown maintenance work & give the information of respective dept. & supervisor. 7. Update daily engineering logbook with sign. 8. Attending the shutdown activity. 9. Carry out filter cleaning activity. 10. Assemble & dismantle work of Reactors & centrifuge. 11. Removing & shifting works of Reactors & centrifuge. 12. Fabrication & installation of utility pipings & structures across the plant. 13. Repairing of transfer pumps, mechanical seal, valves etc. 14. Follow the EHS norms & using PPE while carrying out the maintenance activity. 15. Keep appropriate & clean tool boxes, workshop, equipment’s and facility.
Role & responsibilities Working in shift (First shift, second shift & night shift). 2. In case of shift persons absent carrying out the activity of shift. 3. Start & stop activity of chilled water plant, brine plant & air compressors cooling towers. 4. Received maintenance job requisition in all plant & departments & take immediate action. 5. After completion of Job completed the job requisition with sign. 6. Carrying out the preventive maintenance activity as per instruction of his supervisor & seniors. 7. Attending breakdown maintenance work & give the information of respective dept. & supervisor. 8. Update daily engineering logbook, equipment logbook.(chilled water plant, air comp, brine plant) 9. Attending the shutdown activity. 10. Cooling tower sump, condenser cleaning work. 11. Vacuum pump leakages attend. 12. Follow the EHS norms & using PPE while carrying out the maintenance activity. 13. Keep appropriate & clean tool boxes, workshop, equipments and facility. 14. Carry out filter cleaning activity. Attending pumps gland leakages, replacing work of mechanical seal, bearings etc
1. To carry out Production Activity in Shift as per Shift Incharge instruction. 2. To operate all the Equipments as per the SOPs. 3. To charge & monitor the batches as per the BMR. 4. To carry out operation like Centrifuging, Filtration, Milling, drying, sifting, drum handling, packing. 5. To fill the documents like daily check lists & BMRs, ECRs and other documents. 6. To carry out daily verification of Weighing Balances. 7. To clean all the Equipments as per the ECR. 8. To pack the Finished Product as per the Instruction. 9. To maintain General Housekeeping of Plant & PPA.
Role & responsibilities Please Note : Male candidate required. General Administration - Guest Management /Audit Management - Canteen Management - Laundry Management - Visitor Management - Transport Management Contract Labour Management: - Cordinating with respective Dept. Head and Manpower Supplier to finalised requirement monthly and ensure same is fulfilled. - Monthly checking of Contractor bill and payment along with statutory compliances and ensure wages are paid within on or before 7 th day of respective month Monthly purchase requisition and Admin Bill processing in SAP - Generating PR in SAP Ensure all request for Purchase are done in SAP and requirements are fulfilled within time line - 'Service entry of Admin Bills All payment to vendors are done with 07 days from receive invoice Security Management - Ensure 100% Compliance and Vigilance in Man & material movement - Reconciliation of inward, outward and returnable/ non-returnable material - Deployment of Security Personnel as per sanction strength
Note - Male candidates will be preferred 1. Job role : Supervisor QC-Documentation & QMS 2. Preparation of SOPs and Validation protocols as and when required. 3. Carry out calibration of the Instruments as per the laid down procedure. 4. Daily Monitoring of Temperature, Humidity, Cleaning & pressure differential records review. 5. Microbiological Analysis of Purified water, Potable water and Finished Product. 6. Environmental Monitoring of Unit I, Unit II, Unit III, Stores and Microbiological department. 7. Carry out qualification / requalification of equipment in Microbiological department. 8. Review of the preparation of Media, Culture dilution, culture maintenance and Growth Promotion Test. 9. Carry out MLT validations of the finished products. 10. Review of the analysis and reports in the microbiology section. 11. Work allocation and its implementation and to update the daily status to department head or section head. 12. Carry out investigation for failure of microbiological analysis (Water, Environment, Product, Growth Promotion test) & Investigation for failure of water for chemical analysis. 13. To initiate the change control and perform related activity. 14. To initiate the deviation form and perform related activity. 15. Initiate the CAPA and perform related activity. 16.Implementation of Good laboratory practices, Good documentation practices as per standard operating procedures in Quality control department. 17.To carry out Trending data of Environmental Monitoring, Water as per frequency. 18.To carry out Dirty / Cleaned equipment Hold time Study. 19. Co-ordinate with QA, Production and Stores department for related activity. 20. Co-ordinate with engineering department for maintenance activity. 21.Preparation and Review of Certificate of Analysis (COA).
Preferred candidate profile - Male Role & responsibilities - 1 .Knowledge in various dosage forms especially Solid- Oral dosage form- tablets, capsule and pellets as both immediate release and modified release. 2 .Familiar with Pharmacokinetic Principles, ICH guidelines and regulatory requirement (US/EU/ROW). - Formulation development for Regulated Market like US,EU and ROW countries - Preformulation, prototype development, lab scale stability studies. - Knowledge on QbD development. - DOE knowledge preferred. - Technology transfer document preparation like SAP code, MFC, PVP, HTP and SSP. - Technology Transfer at plant level.