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QA/QC Manager Resume Example

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QA/QC MANAGER
Executive Summary
Quality professional with 16 years of progressive experience with sound knowledge in Quality Assurance, Quality Control, and Analytical Research and Development functions. Successful PAI, Pharmacovigilance and GMP audits by FDA with no 483's. Expertise in product non-conformance investigations, deviations, CAPA's, Change management, CMO management, Vendor audits, facility audits and Quality document management. Process validation of Solid, Liquid, Nasal Sprays, Ointments, Gels and Transdermal dosage forms.  Excellent management skills. Hands on experience in handling HPLC systems (Agilent 1100, Waters, Shimadzu, equipped with PDA, RI, Florescent and Dual Wavelength detectors); GC systems (Agilent 6890, 5890, Shimadzu 17A); Empower, Chemstation, Class VP soft wares; UV, IR instruments, USP Type I and II dissolution apparatus, Osmometers, Particle/droplet size distribution (liquid) by laser diffraction, spray pattern and so on. Working knowledge of Document Control Management system, SAP, LIMS, Computers, MS office suite, internet browsing and literature search
Core Qualifications
  • Quality Management (QC & QA)
  • Regulatory Affairs
  • Risk Management
  • Complaint Management
  • Change Management
  • Regulatory Audit Hosting
  • Pharmacovigilance
  • Quality Metrics
  • Vendor Management
  • Leadership
  • Interpersonal Skills
  • Analytical Skills
  • Time Management
  • Communication Skills
  • Quality Agreements
Professional Experience
Company NameQA/QC Manager04/2014 to 10/2015
  • Monitoring of cGMP compliance (21 CFR Part 210 and 211) and compliance to approved procedures Conducting cGMP and On-job training programs Vendor audits and Internal audits Management of document change control and change management system Tracking and management of Deviation and Quality Incidents Handling of non-conformances and QA investigations Tracking and management of CAPA's Handling of market complaints and adverse events Handling of Out of Specification and Out of Trend Investigations Management of Stability programs and data compilations for Internal and Regulatory requirements Equipment qualifications Handling Technology transfers and product transfers Release of raw materials, packaging materials, in-process and finished products Handling of Customer and Regulatory Audits Documentation: Site Master File and Validation Master Plans Vendor Audit Reports Standard Operation Procedures General Test Procedures and Standard Test Procedures Master batch and packaging records Sampling and Comparative Protocols Sampling Plans and Inspection Attributes as per ANSI/ASQ Z1.4-2003 Protocols and report for Technology Transfers, Process and Packaging Validations, Cleaning Validations Stability Studies Hold Time Studies, Equipment and Area Qualifications including HVAC Annual Product Review (APR) Tech Transfer Protocols and Reports Designing of In-house labels Other related documents Other routine Quality Assurance activities.
Company NameQA Manager04/2014 to 10/2015
  • Monitoring of cGMP compliance (21 CFR Part 210 and 211) and compliance to approved procedures Conducting cGMP and On-job training programs Vendor audits and Internal audits Management of document change control and change management system Tracking and management of Deviation and Quality Incidents Handling of non-conformances and QA investigations Tracking and management of CAPA's Handling of market complaints and adverse events Handling of Out of Specification and Out of Trend Investigations Management of Stability programs and data compilations for Internal and Regulatory requirements Equipment qualifications Handling Technology transfers and product transfers Release of raw materials, packaging materials, in-process and finished products Handling of Customer and Regulatory Audits Documentation: Site Master File and Validation Master Plans Vendor Audit Reports Standard Operation Procedures General Test Procedures and Standard Test Procedures Master batch and packaging records Sampling and Comparative Protocols Sampling Plans and Inspection Attributes as per ANSI/ASQ Z1.4-2003 Protocols and report for Technology Transfers, Process and Packaging Validations, Cleaning Validations Stability Studies Hold Time Studies, Equipment and Area Qualifications including HVAC Annual Product Review (APR) Tech Transfer Protocols and Reports Designing of In-house labels Other related documents Other routine Quality Assurance activities.
Company NameQC Manager02/2011 to 04/2014
  • Supervised a team of twelve analyst Review and approval of SOP's, STP's and Specifications Review of analytical documents Ensure all the analysts to follow SOP's and perform testing as per approved test procedures, cGLP and cGMP practices Conducted investigations on product/material test result failures and out of trends Co-ordination with external parties for product transfers/technology transfer Participating in customer audits Participation in vendor qualifications Co-ordination with Regulatory group in supporting ANDA filings Compilation of responses to FDA deficiency letters for the filed ANDA's Improving Laboratory systems Co-ordination with operations group for timely releases of Raw materials and Finished product testing for the market releases Review of analyst performance and conducting training if necessary Maintaining QC lab in compliance to safety and regulatory requirements.
Company NameSr. Scientist07/2010 to 12/2010
  • Worked as a project lead for liquid oral projects and successfully completed three liquid projects (formulation development, analytical method development and technology transfer) Developing analytical methods according to Regulatory market requirements Calibration of instruments Maintenance of lab according to GLP Preparation of method validation protocols and reports Performing equipment qualification Providing training for new employees Trouble shooting routine analytical issues Preparation of Standard operating procedures Review of analytical documents.
Company NameChemist II11/2006 to 07/2010
  • Analyzing samples according to Regulatory market requirements Calibration of instruments Maintenance of lab according to GLP Preparation of STP's and work sheets for regular analysis Performing needful analytical work to file ANDA Performing needful work to respond FDA queries after submission of ANDA's Maintaining calibration records for all analytical instruments Preparation and qualification of in-house working standards Review analytical documents Analyze and release of Raw materials, Packaging materials, In-process, Finished product, and Stability samples Hands on experience in the analysis of Liquid Orals, and suspensions.
  • Preparation of SOP's Handling of QA activities like line clearance for dispensing, manufacturing, -packaging operations, and in-process checks, Issuance of batch records for production operations Review of executed batch records Investigation of market complaints Participated in Lab investigations and production related investigations Handling products related to DEA regulations.
Company NameQC-Chemist11/2004 to 09/2006
  • Development of analytical methods for Formulation R & D products using HPLC, and GC.
  • Validation of Analytical test methods according to ICH guidelines.
  • Preparation of SOP's and COA's Evaluation of impurity profiles.
  • Analysis of in-process, finished product and stability samples Maintaining GLP environment in Lab Maintaining Lab records and Equipment records Allotting work to the other chemists Performing needful work to submit ANDA's Performing needful work to respond FDA queries after submission of ANDA's Maintaining calibration records for all lab related instruments.
  • Preparation of specifications for new drug products according to ICH guide lines Preparation and Qualification of in-house working standards Checking of documents Hands on experience in maintaining HPLC and GC Releasing of Raw, In-processes and Finished products on time Hands on experience in the analysis of Liquid orals and Nasal Sprays.
Company Name12/2002 to 10/2004
  • Analyzing samples according to Regulatory market requirements.
  • Calibration of instruments.
  • Maintenance of lab according to GLP.
  • Preparation of STP's and work sheets for regular analysis.
Company NameChemist01/2002 to 12/2002
  • The company is part of the Jupiter Bio Sciences Limited, which is engaged in the manufacturing of Amino Acids, their derivatives and Peptides by synthetic and Bio separation processes.
  • Developing Analytical methods for new products and non-pharmacopoeia on -HPLC and GC and analyzing samples Preparing the samples for analysis using Derivatization methods Preparing Analytical Standard Operation Procedures for sophisticated -instruments like HPLC, GC, Polari meter etc.
  • Preparation of specifications for new products and their raw materials Maintaining the control sample register records for all the working -reference standards and dispatch records for out going samples Maintaining the calibration and annual maintenance contact records for -the instruments Preparation of weekly and monthly reports Hands on experience in analysis of solid dosage forms.
Company NameChemist12/2000 to 01/2002
  • Trained on HPLC and GC Maintenance of HPLC and GC instruments, instrument log books and -sample inwards Calibration of instruments like HPLC, GC, Polari meter Training on Preparative HPLC Method development activities on both analytical and preparative -HPLC's under the guidance of senior person.
Company NameChemist06/1997 to 07/1998
  • Analyzing in-process samples based on wet procedures.
Education
M.S:Analytical Chemistry2000Andhra University, City, IndiaAnalytical Chemistry
B.S:Chemistry1997Andhra University, City, IndiaChemistry
Skills
analyst, agency, Audit Reports, Calibration, change management, oral, compliance audits, derivatives, Designing, direction, Documentation, employee training, forms, GC, GMP, GLP, HPLC, HVAC, Inspection, Internal audits, leadership, letters, market, materials, Works, Packaging, processes, product development, product testing, project lead, Protocols, Quality, QA, Quality Control, Quality Assurance, Research, safety, SOP, Specification, training programs, Trend, Trouble shooting, Validation
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Resume Overview

School Attended

  • Andhra University

Job Titles Held:

  • QA/QC Manager
  • QA Manager
  • QC Manager
  • Sr. Scientist
  • Chemist II
  • QC-Chemist
  • Chemist

Degrees

  • M.S : Analytical Chemistry 2000
    B.S : Chemistry 1997

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