Role & responsibilities 1. Sampling and testing of water samples. 2. Preparation of media and growth promotion. 3. Environmental monitoring of plant and QC laboratory. 4. Hose pipes and drain point monitoring. 5. Calibration of laboratory instruments. 6. Preparation of certificate of analysis for water samples and preparation of trends. 7. Microbiology testing of Raw materials, packing materials, finished product and stability samples. 8. Monitoring of compressed air. 9. Culture maintenance. 10. Preparation and revision of relevant standard testing procedures. 11. Media, chemicals and glassware stock management. 12. Daily monitoring and recording of temperature and pressure differential of the laboratory. 13. Fumigation of microbiology laboratory. 14. In addition to the above to follow the instructions given by Head/Designee-QC.
Job Responsibilities: 1. To carry out the in-process activities at Warehouse, Manufacturing, Primary Packing & Secondary Packing Areas & complete the documentation works online. 2. To allocate, check and monitor the In Process Quality Assurance work to all IPQA Personnels in absence of IPQA Manager. 3. To collect analysis sample like in-process, finished products, validation sample, control sample, stability samples (but not limited to), customer sample and submit to QC for analysis. 4. To withdraw & charge the Stability Samples as per the Stability Study Protocol & update the respective logbooks. 5. To review completed batch records for all enclosures, data entries etc. and submit to Head QA / Designee for approval. 6. To coordinate with production for online completion of records. 7. To verify the batch numbering for products and verification of Mfg and Expiry Date. 8. To guide the IPQA subordinates about the process & completion of online documentation in the manufacturing & packing areas. 9. To review all the logbooks for production, store and engineering area. 10. To participate in validations / revalidations of processes/ procedures which are carried out as per validation master plan. 11. To participate in the qualification of new equipment which are carried out as per the procedure and this equipment are released for routine use after satisfactory completion of the qualification. 12. To assist Head QA / Designee in preparation and maintenance of batch records. 13. To assist Head QA / Designeein providing documents like specifications, protocols, reports etc. to regulatory affairs department. 14. To assist Head QA / Designeein control and issuance of batch records, formats, protocols etc. 15. To assist Head QA / Designeein execution of change controls, deviations etc. and to take follow up.