Jubilant Bhartia Group
Long Description
Shall be responsible for the following activities:
➢ Shall be responsible for review of process validation protocol/ Process Performance Qualification protocol and reports.
➢ Shall be responsible for review of Validation Master Plan.
➢ Shall be responsible for process validation schedules in the Validation Master plan ➢ Shall be responsible for preparation /review of summary report of Validation Master Plan.
➢ Shall be responsible for updating / review of process validation history cards.
➢ Shall be responsible for tracking and monitoring of ongoing PPQ batches
➢ Shall be responsible for tracking and monitoring of hold time/stability samples pertaining to intermediate and API PPQ batches.
➢ Shall be responsible for handling of Change Management, Deviations, Out of Trend, Out of Specification and CAPA related closure through Track wise.
➢ Shall be responsible for preparation of Quality Assurance SOPs and review of SOPs related to all plants.
➢ Shall be responsible for compliance of audit observation during the customer and regulatory audits
➢ Carrying out unplanned audits as per the SOP.
➢ Shall be responsible to review of QMS documents in Track wise as per requirement. ➢ Handling of QMS activities in Track Wise system, material management through SAP system and document management through EDMS, as applicable. Track and complete all the QMS activities within the due date.
➢ Shall be responsible for preparation/review of System Based Risk Assessment (Nitrosamine including NDSRIs, GTIs & Azido Impurities, EG & DEG), Quality event related risk assessment & other Risk assessment reports through EDMS.
➢ Shall be responsible for preparation/review of Nitroso impurities risk evaluation and declaration in line with current guidelines through EDMS.
Long Description
Shall be responsible for the following activities:
➢ Handling of manufacturing investigations related to deviations, Out of Trend, Out of Specification for all production plants and closure of the quality event in trackwise.
➢ Handling of CAPA’s & action item projects derived as part of manufacturing quality events and ensuring the closure of event in trackwise.
➢ Handling of effectiveness check derived as part of manufacturing quality events and ensuring the closure of event in trackwise.
➢ Shall be responsible for preparation and review of Annual Product Quality Report (APQR) and Periodic Product Quality Report (PPQR) for all the products as per SOP / schedule.
➢ Shall be responsible for preparation and review of QMS annual trends.
➢ Shall be responsible for maintaining Process validation and other Life cycle documents archival.
➢ Responsible for Site Admin activities in Compliance wire.
➢ Co-ordination for cGMP trainings at site in all functions like QA, QC, Manufacturing, Stores and Engineering
➢ To create training items, curricula, user groups, and assignments of QA function for LMS Compliance wire
➢ Preparation and escalation of Compliance wire enhancement as required.
➢ Ensure cGMP trainings have been carried out as per the schedule
➢ Ensure to train the new joiners on related sop’s and to conduct training as per the approved schedule as and when required.
➢ Responsible for to generate uncontrolled copies from EDMS and also electronically as on required for audit purpose and also to share for the customers.
➢ Shall be responsible for work assigned by reporting Manager.
➢ In the absence of the position holder operational responsibilities delegated to Direct reports or designee.
