Assistant Manager QA
CIPLA Ltd
Total years of experience :16 years, 6 Months
The job profile includes:
•QUALIFICATION & VALIDATION:
•Review of HVAC validation documents.
•Review of Area qualification documents.
•Review of Eqiupment qualifcation documents.
•Handling water system validation.
•Prepration of Validation protocol Potable water and purified water.
•Handling Product validation.
•Prepration of Product validation protocol and report .
•Documentation:
•Compilation of APQR for domestic and regulatoy market.
•Handling rejections (RM & PM)
•Handling Deviation, CAPA and Leading investigation of quality issues and developing systemic action plans to fix root cause, review of audit action plans.
•Review of MBMR & MBPR.
•To ensure the compliance with cGMP.
•Review technology transfer documents and also to facilate pilot scale and commercial batches as a part of TT to LL product ion site
•Preparation of Job Responsibilities and organization chart.
•Responsible For Sop’s Preparation, reviewing and distribution
•Preparation & review of Annual training Schedule & Training Matrix.
•OPERATION:
•To develop procedure for line clearance in production /packaging operations prior to product change over.
•To conduct process control defect analysis with production & take corrective action to prevent reoccurrence in future.
•To conduct periodic cGMP audits (self audits) & initiate corrective actions.
To investigate market complaints & take necessary precautions.
•Review of BPR and BMR for compilation of batch records for Product dispatch.
•onitoring IPQA activities on shop floor through Line clearance for Manufacturing and Packaging activities, and performing In-process test at manufacturing and packing stages like: Proof checks, Yield Reconciliation, check weigher challenging, checking of Consumption & EMRN Approval of DPR.
•Issuance of BMR /BPR /Logs books.
•Ensure Product safety/hygiene and quality shop floor.
•Review and check of Maintenance schedule, Pest control, Calibration of equipment, and Plant hygiene
Review of BMR, PDR and BPR.
•Handling Training Documents and providing training to new employee.
•Responsible for Sop’s Preparation, reviewing and distribution.
•Responsible for assure the compliance to quality during manufacturing and packing.
•Responsible to issue BMR’s and PDR’s.
•Maintain and reviewing of control samples.
•Responsible for Product dispatch inspection and approval.
•Responsible for Final release of product through SAP transaction.
•Responsible for to ensure the finished goods compliance as per requirement.
•Responsible for Batch manufacturing and packing record on line monitoring
•Responsible for Preparing & Reviewing in process documents for VCD &VI.
•Handling packing material technical standards
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