Sana - Executive

Job Description

To follow the safety rules in the premises according to the company norms. To ensure timely completion of SOPs training and on the job trainings related to production department. To review and maintain the training related log books in the department. To Coordinate new joiners for internal and cross functional trainings in coordination with cross functional departments. To coordinate with QA documentation cell for issuance of required documents and submission of completed documents. To prepare the SOP index, Equipment index and format index as per the frequency of QA001, QA007and QA002. To update the schedule manager for SOP related activities (to update SOP effective dates). To upload the SOPs in AIMS (Amneal information management software). To close the training record of employees who left the organization. Preparation of cGMP planner for contractual employees of production department. Operation and cleaning of visual inspection table and Operation of Lux meter. Responsible for Operation and cleaning of Automatic visual inspection machine and X-RAY inspection machine. Responsible to perform visual inspection of the products /media filled vials or PFS as per the sop. Responsible for Maintenance of cleaning in visual inspection. Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by Following HODs instructions and guidance. Monitoring of DP, RH and temperature area in their visual inspection and packing area. Responsible for Maintenance of cleaning in visual inspection and packing area. To maintain the BMRs and other log books in the visual inspection and packing area as per cGMP and SOP. Operation and cleaning of dynamic pass box in visual inspection and packing area. Responsible for Operation and Cleaning of Wrap around labeling machine, Autocartonator machine, Online check weigher, track and trace system, Bopp taping machine with weighing balance and PFS packing area machines. Responsible for Dispensing, checking and receiving of the packing materials from warehouse on need basis. Responsible for labeling and packing of products as per BPR. Responsible for timely completion of calibrations and validations in coordination with EN and QA related to visual inspection and packing area. To handle Quality Management Documents like Change Control, Deviation etc. Job Description Version No:4 Generated By/On: Sanjay Mukhekar [309175] 24-May-2025 12:47:40 PM This is system generated document hence signature is not required. 1 JOB RESPONSIBILITY To prepare Failure Investigation Reports against Quality impacting deviations, Out-of- Specifications and Non-Conformances. To ensure investigations are evaluated and closed out in a timely manner to meet business needs. Responsible for cGMP compliance related to CAPA implementation and to ensure the timely closure of CAPA. To review, develop and introduce systems, practices and cultural changes that enable the department to meet business demands within agreed time frames and expected GXP standards. To perform risk analysis for different process or procedures and implement necessessory mitigation plans through Quality Risk Management (QRM). To provide direct input or coaching support for other functional groups in investigations. To prepare and review of Standard Operating Procedures / Protocols. To perform Gap analysis of defined procedures in Batch Manufacturing Record / Batch Packing Record / Standard Operating Procedure / Protocol and initiation of corrective actions. To participate in Regulatory & Customer Audits. To prepare BMR and BPR. Timely completion of SOPs training and On the job trainings related to respective area