Responsible for preventive & breakdown maintenance for plant equipment, Utilities & Maintenance preventive, predictive and breakdown, Material indenting & inventory control.QMS, Team handling. Water Treatment dept. consist of Reverse Osmosis (R.O Plant), De-Mineralize Plant (D.M Plant), Cooling Towers (Induced draught), and Softeners etc. Looking after Operation and Maintenance activities of PSA Nitrogen plant of capacity . Maintenance of Reactors , Autoclaves , High Vacuum Ejector Systems , Centrifuges, Rotary vacuum Dryers. Operation & Maintenance of thermo pack boilers Shut down activities of plant and related jobs

Good knowledge In stability. Performing Dissolution By HPLC And UV- visible spectroPhotometer. Performing HPLC , Dissolution , Balance calibration. Dissolution studies. Review and revision of analytical reports. Review and verification of log books as per monthly planner. Basic knowledge in ICH guidelines. ,Laboratory, stability, Management,HPLC,Process Development,Product Development,Analytical Research,Analytical Method Development,LIMS,QMS,OOS,OOT,Capa,cGMP

Preparation of SDLC and QMS Documentation Audits Compliance QMS-RCI, Deviation, CC, CAPA and EC.

Responsible for overall Quality control laboratory Implementation of cGMP and good laboratory practices. Handling of laboratory incident, Out of calibration and deviation investigation. Conducted investigations on product/material test results failures and out of trends Review & approval of standard test procedure, specification Handling of laboratory incident, Out of calibration and deviation investigation. Making sure that all deviation, OOS,OOT, incident are investigated and closed before the release of the batch/material

Analysis of Stability and Finished products and maintain GDP and GLP . Follow compliance of current regulations and etc. Testing of Finished Products maintain all GLP document and calibration of Instrument like HPLC, UV spectrometer etc. HPLC, Stability and Working standard section incharge. And also involved in Documentation related activity. Incident, OOS, OOT and CCF initiations and investigation report throug LIR with trackwise. Qc trainings and supporting to RA.

Maintenance of walk-in-type stability chambers Following Stability Studies according to ICH Guidelines. Daily monitoring of Stability Chambers. Stability master schedule preparation and stability samples releasing through LIMS transactions. Planning and monitoring the daily activities & updated to superiors on the observations and outcomes. Preparation of SOPs, STP’s whenever required. To prepare the Finished maters and Stability programing in LIMS. Well experienced in various analysis of Stability Products. Conducting Stability studies & analysis. Review of stability ATR’s and releasing through LIMS transactions.

Review of BMR and other production and quality control related documents. Major experience in API IPQA activities (like: Plant rounding & monitoring). Preparation of APQR.

Roles and Responsibilities Develop new products by formulating, developing, and launching solid oral products. Conduct bioanalytical testing to ensure product quality and stability. Collaborate with cross-functional teams for process development, PDR (Process Development Research), MFR (Manufacturing Formulation Research), FD Trial (First Time Right Trial). Ensure compliance with regulatory requirements through documentation of SOPs, BPRs, and batch records. Provide technical support to production team on product-related issues.

* Activities related to initiation and implementation of Change Controls, CAPAs. Deviations * Showcasing excellence in investigating non-conformances through 5-why analysis and Fishbone diagram. • Preparation of risk assessment for new equipment installations. * Preparation and review of SOPs related to Engineering. • Tracking and control of training related to equipment qualification, revised SOPs, and PM procedures.

Managing Maintenance Operations For up keeping dept. documentation and improvising whenever necessary. The role will be responsible for contributing to the achievement of business unit KPIs through supporting operational and engineering teams in the operation and maintenance of facilities, utilities and process equipment throughout their lifecycle

Selection of batches of Active Pharmaceutical Ingredients (API) for stability studies. Sampling, incubation, withdrawal, analysis of stability samples as per schedule. Review of stability schedule, protocols, summary & stability testing form. Stability study monitoring as per requirements of regulatory authorities, vendor requirements and as per ICH guidelines. Submission of Stability testing form to PRC, RA, CFT and other department as per requirement. Deviation logging, immediate action, impact assessment, investigation, root cause, remedial action and closing within stipulated time in Trackwise (QMS) software OOS, OOT, incidences and deviation PLEASE SHARE YOUR UPDATED CV ON placement@balpharma.com Thanks, Kamal

Analysis of samples as per existing release spe c ifi c ations and testing methods Ensuring strict adherence to Current Good Manufacturing Practice (cGMP) and Current Good Laboratory Practice (cGLP) to maintain high product quality Executing thorough investigation of Out of Specification (OOS), Out of Trend (OOT), and incidents, ensuring the implementation of appropriate Corrective and Preventive Actions (CAPA) when required. Playing a crucial role in Stability Management within Quality Control, including monitoring all stability-related activities and chambers. instrument HANDLED AUDIT FACED USFDA, EUGMP PLEASE SHARE YOUR UPDATED CV ON placement@balpharma.com Thanks, Kamal

performing investigations of deviations, Customer complaints, returns, recurrence review investigation reports, work closely with others on site events to verify scope of investigations, to identify appropriate root cause and derived robust CAPA to prevent and ensure timely closure. process validation protocol and preparation of validation reports Facilitate tracking, trending, closure and management of deviations/ investigations / CAPA systems Audits faced USFDA TGA CDSCO EUGMP PLEASE SHARE YOUR UPDATED CV ON placement@balpharma.com Thanks, Kamal

REVIEWING EXECUTIVE BATCH PRODUCTION AND CONTROL RECORDS (BPCR) FOR ACCURACY AND COMPLIANCE WITH STANDARDS HANDLING, MONITORING, AND CLOSING OF CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) AND CONDUCTING EFFECTIVENESS CHECKS. AUDIT FACED USFDA AUDIT ANVISA AUDIT EU AUDIT DIFFERENT CUSTOMER AUDIT PLEASE SHARE YOUR UPDATED CV ON placement@balpharma.com Thanks, Kamal