Executive - IPQA

In process Quality Assurance & System Compliance: 1.1 Carry out in process quality assurance checks as per the procedure laid down in respective SOP's and BPR, in order to produce product with desired quality. 1.2 Perform AQL checks and packed stock verification as per procedure and carry out sampling as per procedures. 1.3 Perform line clearance checks and propose corrective measures to prevent cross contamination. 1.4 Perform daily verification and calibration of IPQA instruments as per procedure. 1.5 Carry out failure investigation if any. 1.6 Monitor validation batches. 1.7 Verification of Finished Goods Transfer Note. 1.8 Perform line clearance activity in Raw material dispensing Documentation Compliance: 2.1 Ensure online documentation and its correctness. 2.2 Review of executed BPRs to facilitate finished goods release in time as per laid down procedures. 2.3 Ensure the timely revisions and availability of current SOPs. 2.4 Ensure the SOPs are in line with the practice. 2.5 Facilitate timely completion and effective implementation of QMS system. 2.6 Review of Master BPR and SOPs/WIs 2.7 Review of Master BPR for submission batches. 2.8 Review of executed batch packaging record of submission batches. Operations Review: 3.1 Follow up for WIP and under hold batches and ensure disposition. Packaging validation: 4.1 Preparation and review of packaging validation protocol and report. Training: 5.1 Training through classroom training/OJT for all the related SOP's. 5.2 Update of cGMP /GDP knowledge through classroom training. Equipment qualification: 6.1 Perform operational and performance qualification of Equipment. Quality Management System: 7.1 Initiation, investigation, post implementation review of QMS documents such deviation, change control, complaint and OOS/OOT. Follow ups for CAPA implementation updating of closure status and to ensure the effectiveness. Control sample management: 8.1 Daily check of Finished Product Releases and pending batches by QC. 8.2 Inward entry of control samples of finished product, raw material, packaging material by recording the details in LIMS and as applicable. 8.3 Retrieving and issuance of control samples, raw material and packing material on receipt of sample request form in LIMS. 8.4 Ensuring destruction of expired control samples as per SOP and recording the same in LIMS. 8.5 Adhere to all safety precautions, GDP and compliance during every action. Administration of SAP: 9.1 Monitoring/Assessment of Major break down(M2) and its closure. Handling and issuance of BPR/BMR: 10.1 Issuance of additional pages for BPR/BMR Artwork management: 11.1 Review and approval of artwork as per standard procedure. In case of customer approved product ensuring the final corrected artwork is rechecked and approved in line with the customer approved Artwork. Review and approval of artwork change request. CAPA and effectiveness check: 12.1 Review and approval of all the ODF site related CAPA’s 12.2 Co-ordinate with CFT members for documents related to CAPA management and effectiveness check. 12.3 Timely closure of effectiveness check. Provide monthly metrics for CAPA and effectiveness check Audit and compliance management: 13.1 Be a part of handling external (Both customer and regulatory) as well as internal audit. 13.2 Review of audit observation, co-ordinate for preparation of audit response and ensuring the proposed CAPA towards audit finding to add continuous improvements.