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Click here or scroll down to respond to this candidate..Candidate's Name
Quality Control SupervisorRobbinsville, NJ, Street Address
PHONE NUMBER AVAILABLEEMAIL AVAILABLEDedicated professional having 7+ years of experience in providing exceptional Quality Control functions. Quality Control supervisor skilled in developing protocols to positively impact manufacturing quality. Practiced at completing exhaustive tests of incoming materials, components and finished products. Proven experience within pharmaceutical industry performing direct hands-on work in QC functions with strong familiarity of general practices. Excellent analytical, technical, supervision, Investigation and leadership skills. Tactful, Proactive & Responsible for safe and effective quality system, Project management, Quality control, Analytical development & Validation. Sound knowledge of GLP, GMP and routine and non-routine analysis and instrumental techniques such as HPLC, UV- VIS spectroscopy, Dissolution, FTIR, KF, PH meter, Microscopy etc. Skills Demonstrate strong skills in operating and calibrating, work instruction of instruments HPLC, Dissolution, FTIR, UV-Visible, KF Auto titrator, Polarimeter Preparation and execution of Standard Test Procedures of Raw Materials, Excipients and Finished Product Experience in Validation, Method Transfer Protocols for Assay and Dissolution of Finished product Expertise in preparation of Standard Operating Procedures used in Quality Control Department. as per ICH guidelines Evaluation Tests - Disintegration Time, Friability, Dissolution, Particle size Analysis, DSC, Colorimeter Actively participated in FDA Audit by providing necessary documentation, protocols, proceduresInstruments HPLC Dissolution Apparatus. UV-Spectrophotometer. FTIR. Halogen moisture analyzer. Disintegration apparatus. KF auto titrator. Polarimeter. DSC: TA (Q 1000) series (Universal Analysis). Texture analyzer: Stable micro system/U.K...Work History2022/01 - presentQuality Control SupervisorApnar Pharma LLP, Jersey, USA, USA Schedules testing of Raw materials, Stability samples, In-process & Finished products samples. Manages QC team & Compliance activities to achieve key site & corporate objectives. Identifies areas in need of method modification & staff training. Communicate material status and highlight critical path activities in reliability meeting to the management. Act as advisor to team members to meet schedules & resolve method & instrument changes. Write, Review & Revise SOP's, Method, Specifications as required. Initiate Change Controls, CAPA related to investigations, and ensure the closure in a timely manner. Initiate the Quality Events, Deviations, Investigations in timely manner. Manage and Maintain the QMS in timely manner to resolve and/or escalate the issue. Implement Effective CAPA, Continuous Improvement and ensure timely closure of Effectiveness Check. Review or Approve Calibration/PM reports in a timely manner. Perform the Decommissioning/Commissioning activity through the Change control and/or protocol. Prepare the stability protocol, Review the stability data and compilation of stability data within given timeline. Write & Review product transfer & USP/Vendors' method verification protocols & reports. Interact and communicate effectively with other departments and strive for high performance amongst teams. Write & Review OOS & OOT reports and ensure the closure in timely manner. Ensure laboratory is in Inspection ready state and running in cGMP Compliance. Assures Stability Testing plan is maintained & provide data for annual reports for commercial products. Supervise QC chemists, distributes workload and monitor their work, train new chemists and maintain the lab in accordance with cGMP. Interact and communicate effectively with other departments and strive for high performance amongst teams. Communicate project status and highlight critical path activities in a timely manner to management. Initiate investigations for OOS (out of specification) and laboratory Deviations with Corrective and Preventive actions (CAPA) and participate to find root cause for investigation Recommend and implement Corrective and Preventive actions (CAPA) for Product Complaint and Investigation. Assist with ensuring on-time closure of investigation and other Key Quality Indicators where needed...PHONE NUMBER AVAILABLE Prepare and Review relevant SOPs, stability protocols, validation and technical reports to support laboratory functions and FDA requirements. Responsible to initiate and execute Change Controls for COAs, Specification, Methods & relevant to QC laboratory systems following dates/commitments. the change control procedure while ensuring adherence to the closure Prepare an Electronic COA (Certificate of Analysis) for Raw material, Intermediate and Finished products. Evaluate, interpret & present data in most trustable & reliable manner to project analytical expert. Schedule and monitor the stability samples for Finished API METHOD VALIDATION Performed Method Validation studies of Raw materials, Intermediate products and Finished products as per protocol. Performed Method precision, Specificity, Prediction, Solution Stability, LOD/LOQ studies, Ruggedness studies for the Validation of Raw materials, Intermediate products and finished products. Performed Method transfer studies for API/Finished products as per protocol requirements. METHOD DEVELOPMENT Conduct research for method development by HPLC and Dissolution technique and approves modification of formulas, standards, specifications and processes. Communicate new ideas and approaches to appropriate personnel. Take analytical lead on the assigned projects and participate cross-functional team to support analytical strategy for product development. Quality Control AssociateAurex Laboratories LLC, Jersey, USA, USA Carry out daily functions of Quality control laboratory and analytical testing Plan. Worked on raw material, packaging materials, in-process, finished product and stability testing as per GMP, GLP standards using instruments such as HPLC, UV/Vis, FTIR, Dissolution apparatus USP (I & II), Particle size analysis. Prepared specifications and standard testing procedure for raw materials, excipients, Finished product. Trained, Supervised Trainees/new joiners laboratory work. Calibration and maintenance of the Instruments- HPLC, Dissolution, Melting point, FT-IR, UV-visible, KF auto titratr, Weighing balances, Polarimeter, pH machine, etc. Worked on method validation including assay and Dissolution for Finished products and cleaning method validations. Qualified and validated standard test methods for raw materials, excipients and finished products. Created and reviewed technical documentation including protocols, analytical test procedures and change controls. Has reviewed and wrote technical reports, procedures, investigation and protocols. Performed cleaning verification on instruments after batch execution... Review and determine the acceptance of analytical work in terms of accuracy and consistency in compliance with SOPs and principles of GMP to support regulatory submissions.PHONE NUMBER AVAILABLE Assistant ProfessorVishnu Institute of Pharmaceutical Education & Research, Hyderabad, India, India Advised students on academic plan and course selection. Taught introductory and upper level courses in Pharmaceutical Technology. Developed and delivered engaging lectures to undergraduate and graduate students. Supervised and evaluated students' laboratory work. Collaborated with admissions department on establishing prerequisites for undergraduate and graduate students.PHONE NUMBER AVAILABLE Project TraineeInternational Specialty Products, Hyderabad, India, India Academic Projects Optimization of Plasticizer concentration for different film forming polymers used for pharmaceutical coating system. Conducted quality control tests and directed test procedures. Organized lab test solutions, compounds and reagents. Preparation and Evaluation of Tablets, Capsules and Pellets. Pre-formulation & Spray drying of poorly soluble drugs. Operating Tablet Compression machine and Tablet Coating equipment. Studied physico-chemical properties of drug with different polymers. Selection of suitable polymer and drug to polymer ratio to increase bioavailability. And dissolution characteristics of drug. Optimization and concentration of some selected plasticizer for particular polymer. Determine compatibility of different polymers with different polar and non-polar plasticizers. Operation, instrumentation & Data processing of DSC and Texture Analyzer for mechanical strength. Of coated tablets.EducationPHONE NUMBER AVAILABLE Masters: Pharmacy: PharmaceuticsSri Padmavati Mahila Vishva Vidyalayam - IndiaPHONE NUMBER AVAILABLE Bachelor: PharmacyNagarjuna University - India |
