Kreative Organics Private Limited

Jeedimetla, Hyderabad

1.BMR Preparation and BMR Reviewing.2.Change Control Reviewing and Closing.3.Protocol Preparation and Closing.4.Report Preparation and closing.5.Deviation Preparation.6.Qualification Preparation.7.Raw material indent in SAP.8.System work should be required.9.Consumption coefficient Preparation.

Kreative Organics Private Limited is a manufacturer of Active Pharmaceutical Ingredients (APIs) for the world market. Kreative started operations in 1990. Kreative was established by Dr. S. Krishnamohan. Dr. Krishnamohan was formerly with TIFR, BARC, Caltech and NASA. He is a scientist of international repute and runs Kreative with professionalism and a focus on innovation.Kreative maintains strict quality standards and has developed a robust quality system around which all of our products are manufactured.Kreative invested in a state of the art cGMP facility in 2005 and expanded it to a US FDA class facility in 2013.Kreative, is WHO GMP certified and has been successfully been audited by the US FDA in Feb 2020.

Kreative Organics Private Limited is a manufacturer of Active Pharmaceutical Ingredients (APIs) for the world market. Kreative started operations in 1990.Kreative was established by Dr. S. Krishnamohan. Dr. Krishnamohan was formerly with TIFR, BARC, Caltech and NASA. He is a scientist of international repute and runs Kreative with professionalism and a focus on innovation.Kreative maintains strict quality standards and has developed a robust quality system around which all of our products are manufactured.Kreative invested in a state of the art cGMP facility in 2005 and expanded it to a US FDA class facility in 2013.Kreative, is WHO GMP certified and has successfully been audited by the US FDA in Feb 2020.

Plan and manage all activities of Laboratory (analysis, chemical management, calibrations, standards management, investigations, incidents or out of specifications, method optimizations, validations .Manpower Planning ,Preferred candidate profile Having 2 to 3 Years of experience as a manager(Only Male).

1. To make sure manufacturing operations are carried out in conformance with cGMP.2. To make sure all production records, BMRs, equipment performance, production employees attendance are recorded properly.3. To make sure all the production personnel who are directly involved in processing follow good hygienic practice and follow cGMP.4. To follow all activities in the plant, especially those that are carried out during non-General Shift.5. To report any irregular activities carried out during non-General Shift to his production manager.6. To make sure all equipments are in good condition before processing.7. To make sure that production areas clean and good house keeping.8. To make sure that all deviations occurred during in process is reported to production head immediately.9. To make sure that the status of the equipment is updated after each significant operation.10. To make sure that all the equipment used for the manufacturing are clean and dry as per the equipment cleaning procedure.

. Maintaining Working Area Hygiene Documents, Floor cleaning, Daily calibration records as per standard operating Procedure2. Maintaining Proper Labelling System each product.3. Maintaining MSDS (Material Safety Data Sheet) Normal all lab chemicals.4. Maintaining Product Log Books, Patents and R&D Documents.5. Cleaning of the Glassware.6. Maintaining lab chemicals inward documents.7. Following the instructions of shift chemist.8. Before start the work persons should wear Apron, Nose masks, Gloves, Goggles and safety shoe during process operations.9. Arrange several types of Set-ups in R&D Laboratory.10. To ensure proper allocation of works to the Lab assistant.11. Maintaining online documentation.12. Ensure the all standards; Reagents are within the valid period.

1. Operation and maintenance of boiler.2. Charging required quantity of coal in to the boiler.3. Cleaning of boiler.4. Feed the required water level.5. Maintain parameters as per boiler operation SOP.6. Ensure safety practice being followed during boiler operation.7. Ensure boiler surroundings cleanness.8. Regenerating and feeding of softener water.9. Report to maintenance in-charge / Manager for any abnormalities.

1. Ensure easy traceability of document/form/SOPs/log books etc issuance and retrieve as per approved written procedures.2. Review and approve procedure and records of raw materials, intermediates, packaging and labelling materials.3. Review and approve completed batch production and laboratory control records before release of saleable intermediates and API for distribution.4. Review and approve of annual product quality review and applicable QMS tracking reports (Change management, deviation management and CAPA management etc.)5. Providing training to cross functional team members on cGMP procedure and revised standard operating procedure, protocols where applicable.6. Handling of QMS documents such as deviations, out of specifications, complaints, returned goods, change controls, incidents, recalls, vendor qualification and CAPA.7. Review & Approve validation protocols and preparations of reports as applicable.8. Ensure that all applicable CAPAs are implemented and effective.9. Approve all specifications and master production instructions.10. Verify the maintenance and calibration data critical equipments as per approved procedure.11. Review and approve stability protocols and reports of API and/or intermediates as applicable12. Delegate applicable QMS activities to immediate sub-ordinates on need basis.13. Participate in self-inspection, other customer/regulatory inspections14. Approve all procedure impacting the quality of intermediate or APIs; production and control operations are clearly specified in written procedure and adopt GMP requirement.15. Approving raw material, intermediate & API contract manufacturer if applicable as per vendor qualification procedure.16. Review and approve of risk assessments reports for product & other risk assessment.17. Review and approve of equipment and other qualification documents.18. Responsible for the vendor auditing (Vendor, Supplier and External labs) preparing report & review and approve of audit co

1. Master STP and relevant work sheet and AR review/ revision.2. Analytical Method validation protocol, monitoring and report (9 No's - 2020)3. Investigations of incidents (139 No's - 2020)4. QC SOP revision (Review, Print, signature followup)5. Review of daly, monthly, quarterly and annual calibrations and schedules.6. Organized data backup as per the schedule7. Stablity study initiation as part of CCF/ Add on batch. accordingly protocols to be review and approval8. Review of IM & FP AWS recordsQMS:12. Change control handling (66 No's)13. Deviation Handling14. OOS handling15. Weekly meeting preparation16. MRM preparation17. Audit support.18. CAPA followup19. CAPA effectiveness20. Internal audits followup and closure

1. To Follow the GMP, Safety and Environment and Environmental policy and adhere to other policies of the company.2. Take Initiation to follow-up to procure the hardware, software for computers, applications, instrument related Equipments.3. Maintain the Servers of QC Lab in Good condition4. Resolve the problems in any software and hardware by coordinating with Service providers.5. Responsible for DATA Backup & Restore of QC Laboratory systems As per SOP.6. Maintaining of Network Diagram upto date.7. Creation, Modification, Disable of Users in Computerized systems of Empower 3 Application Server Lab solutions and Windows(Domain & Workgroup) Password Management as per SOP.8. Performing the Computer validation As per the SOP or Coordinate with External agency for the activity as per agreement and coordinating with Cross-functional teams for risk Assessment during CSV.9. Creation, Disable of projects in Empower Application Server and Standalone Instrument Systems.10. Prepare and Review of Procedure pertaining to IT related role in QMS.11. Raising and Evaluation of changes route to change control procedure pertaining to IT.12. Reporting of Deviations/incidents and Monitoring and implementation of Corrective And Preventive Actions pertaining to IT Procedures.13. Maintaining of Enterprise and Standalone applications used in Quality Control Departments (Ex: Empower, Lab solutions).14. Co-ordinating with Vendor/Supplier during installation and At the Time of troubleshooting of Computer Systems in QC Lab.15. Administration of Anti-virus Server and Network Configurations, Monitoring of Event Logs for updating data and virus traces.16. Daily Checking of Internet Connections (LAN,WAN),Virus Logs, Antivirus.17. Solving the Problems if Any Electronic Mails issues & Configurations.18. Solving the Network problems to Connect Various Locations.19. Update Windows Updates & Patches in all PCs.20. Connecting Network Printers.21. Prepare Tentative budget as per require

1. To ensure compliance with Good laboratory practices and Good manufacturing practices.2. Should be follow laboratory safety personal protective equipments while handling analysis.3. Based on work allocation analysis should be perform and same day document completion.4. All the analysis of raw materials, in-process, intermediate, stability, Recovery solvents, R&Dsamples and finished product HPLC and GC analysis as per procedure.5. All working standards HPLC and GC related analysis planned as per schedule date.6. Working standard should be use by ensuring validity of standard within the period.7. Chemist should be ensuring before using the instrument status and calibration of instrumentand earlier analysis results should be ensure.8. Chemist should be ensure before starting analysis availability of standards, chemicals andglasswares etc.,9. Analyst should follow good laboratory practices laid down in the quality control laboratory.10. Analyst should follow after completion of chromatography analysis ensure the results anddiscard the solutions if results within the specification.11. Analyst once started the sequence set of sample loading same day next day need to processyesterday samples then only go for new work.12. Analyst should process the samples contemporaneously if any abnormal results observedinform immediately senior supervisor/reviewer/designee then only next decision to be taken.13. Analyst is responsible for analysis and documentation and sample disposition.14. Analyst is responsible for laboratory cleaning, instrument cleaning and maintenance in goodcondition.15. Results are reported as per rounding of the SOP.16. Equipments calibration shall be performed as per internal calibration master schedule.17. After usage of the working standards and reference standards it shall be kept in designatedplace.18. Monitoring the daily room temperature and its recording as per procedure.

Maintaining Working Area Hygiene Documents, Floor cleaning, Daily calibration recordsas per standard operating Procedure2. Maintaining Proper Labelling System each product.3. Maintaining MSDS (Material Safety Data Sheet) Normal all lab chemicals.4. Maintaining Product Log Books, Patents and R&D Documents.5. Cleaning of the Glassware.6. Maintaining lab chemicals inward documents.7. Following the instructions of shift chemist.8. Before start the work persons should wear Apron, Nose masks, Gloves, Goggles and safetyshoe during process operations.9. Arrange several types of Set-ups in R&D Laboratory.10. To ensure proper allocation of works to the Lab assistant.11. Maintaining online documentation.12. Ensure the all standards; Reagents are within the valid period.