QUALITY COMPLIANCE AND SYSTEM: 1.1 Documentation 1.1.1 To ensure online documentation related to current good manufacturing practices (cGMP). 1.1.2 Continuous improvement and review for upgrading existing SOP's with respect to compliance to global standards. 1.2 Quality Management System 1.2.1 Ensure the compliance of existing SOP's related to Equipment Qualification, area qualification, HVAC revalidation, temperature mapping, SMF, VMP etc. 1.2.2 Ensure that change controls are appropriately evaluated as per change control procedure. 1.2.3 Ensure that deviation is evaluated as per deviation procedure. 1.2.4 Ensure that CAPA are evaluated as per CAPA procedure. 1.2.5 Ensuring and practicing Good Documentation practice in Department. 1.2.6 Ensuring and Monitoring the GMP compliance in department
QUALITY OPERATIONS 2.1 Authorized to issue and control 2.1.1 Validation / Qualification Protocol numbers. 2.1.2 Room Identification numbers for all department. 2.1.3 Equipment identification numbers for Production, Warehouse & Engineering equipment. 2.2 Authorized to review, approve and control of document 2.2.1 Equipment Qualification document protocols and reports. 2.2.2 Utilities Qualification protocols & reports. 2.2.3 Area Qualification protocols & reports. 2.2.4 Validation Master Plan and Project Plans. 2.2.5 Site Master File. 2.2.6 User requirement Specification. 2.2.7 Standard Operating Procedures. 2.2.8 Issue and control for Qualification/Validation/Miscellaneous protocol numbering, Equipment/Instrument/Utilities/Room/Area identification numbering. 2.2.9 Prepare, review, issue, retrieve and control of documents like Equipment/ Utilities/Area/Instrument qualification protocol and report. Temperature mapping protocol and report. 2.2.10 Prepare, review and issue Cleaning validation/Process validation/Cross contamination/ Hold Time study/Miscellaneous protocol and report. 2.2.11 Review and approval of FAT protocols and its execution. 2.2.12 Monitor, execute and compiled all qualification and validation related activities. 2.2.13 Perform DEHT and CEHT study on worst case molecules. 2.2.14 Communicate with R&D, Regulatory affairs and CQA related to qualification and validation related documents. 2.2.15 Monitoring and review of calibration and engineering related activities. 2.2.16 Monitoring and review of computer system /PLC validation related activities. 2.2.17 Perform the activities allotted by section in charge. 2.2.18 Impart the training related to GMP, qualification, validation, and guideline updated. 2.2.19 Review APQR annexure for equipment and HVAC qualification details. 2.2.20 Prepare and review risk assessment. 2.2.21 Perform assigned activity from QMS tools like change control, CAPA, deviation etc. 2.2.22 Initiate any QMS tools in Trackwise as per the need.
