Job
Description
Job Description To Prepare new SOPs as per required, revise existing SOPs based on periodic updation and as per internal & external audit recommendation after that review and implemented SOPs of Production department. To Carryout process validation and cleaning validation in coordination with R&D, QC and QA. To review the acceptance criteria is fulfilled for new molecules as well as modify process for existing molecules, also ensure all validation protocols and reports are reviewed accordingly. To Ensure the compliance for cGMP and Safety in production area to work in safe work environment and ensure the subordinate are working in safe condition. To ensure plant facility is always ready for facing internal and external audit. Review audit report and to provide CAPA for all observation and implementation of CAPA. To monitor and review temperature, Humidity, and differential pressure records in clean area (Level-II & III). To ensure that the required documents are maintained as per cGMP and USFDA guidelines and to verify filled documents BMR/BPR/BCR etc. To ensure adherence to SOPs and cGMP during manufacturing operation in the production department. To raise online incident, deviation (Planned/ Unplanned) and change control for new products and existing products etc. and to be closed after completion of activity along with preparation of supporting documents for closing. To investigate (OOS/ Incident/ Deviation) the failure of batches as and make a report with conclusion of root cause/ Probable root cause and CAPA. To initiate CAPA for evaluation and effectiveness of CAPA. After completion of activity CAPA to be closed along with preparation of supporting documents. To prepare and review BMR/BPR/BCR etc. for new products and enhance batch size of existing products as per process given by R&D with related to plant. To revise BMR/BCR etc. according to internal/external audit, validation report and RA recommendation. To prepare equipment and process mapping details, change summary, Equipment comparison, Process comparison, Risk assessment, Errata, Quality comparison/ equivalency and process flow diagram. To update list of authorised personnel entry into production area, Organogram, List of SOPs for revision, List of change control/ CAPA/ Deviation (Planned/ Unplanned)/ OOS/ Incident/ Errata/ Product details/ Equipment details/ Risk assessment for timely closing before due date. To prepare and review Protocols and Reports for area qualification & requalification, Calculator validation, Excel sheet validation for calculation of weighing balance accuracy and precision check log and Intermediate re-analysis for re-test period etc. To generate the online training in AIMS software through issuing/requesting related consulting with concern department. Functional and Cross functional training to be imparted to new joined employee for job specific and job oriented and existing employee as per training need identification and BMR/BCR/LCS etc. To prepare Limit calculation sheet (LCS) for new products of API for cleaning of equipments and existing product in case enhance batch size and change in API equipment based on validation recommendation. Co-ordinate with QA, QC, R&D, Warehouse, Engineering, ADL, and RA department for related to documents preparation, if any failure of products and compliance. To co-ordinate with QA department for documents issuance/submission and warehouse for RM, Intermediate, API issuance/submission as per requirement. To be maintained plant/process related consumable items Inventory as per requirement. Execute batch processing tasks according to standard operating procedures (SOPs), Batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch packing Record (BPR), and maintain the details of records in equipment usage logs Ensure that all steps are carried out accurately and in a timely manner. To take training online in AIMS software. Qualifications Qualification : MSC/BE or BTECH Chemical Engineering
