V.Madhava Rao
Mail : madhu.biochem AT gmail.com
Pharmaceutical Experience :
Organization : Sri Vyjayanthi Labs Pvt. Ltd. Andhra Pradesh.
Duration : 13th June 2011 to till date.
Present designation is Manager-QA
Review, Approval, Issue and Authorization of :
** Quality system procedures (QSP)
** SOPs & Formats
** Master Formula Records (MFRs) & BPRs
** Specifications & Methods of Analysis (MOA)
Preparation, Review and Approval of Major documents like :
** Drug master file (DMF)
** Site master file (SMF)
** Validation master plan (VMP)
** Product quality review (PQR)
Investigation, recording findings, review and propose CAPA for the following :
** Customer complaints
** Deviations
** Out of specification (OOS) of Raw material, Intermediate and Finished Product
** Out of trend (OOT)
** Out of calibration (OOC)
** Incidents
** Non- Conformances (NC)
Review and approval of Protocols & Reports of :
** Validations
** Qualifications
** Stability study
** Method transfers
** Environmental monitoring
** Transport verification
Responsible for all mail responses to :
** Regulatory authorities
** Customers
** Complaints
** Contract manufacturers
** Review and approval of Change Controls
** Conducting internal audits
** Participating in Regulatory Inspections
** To Propose and implement corrective and preventive actions (CAPA) for observations made in internal and external audits
** Training to personnel on cGMP systems
** Responsible for Management Review Meetings (MRM)
** Monitoring of GMP related activities in all departments
** Supervision of QA activities like issuances, retrieval, documents review like BPRs, analytical records and audit trails.
** Approval of vendor questionnaires and quality agreements
** Responsible for vendor Audits
** Authorization of User Requirement Specifications
** Review and approval of new equipment drawings
** Review and approval of Layouts (new/revised)
** Review of calibration certificates and preventive maintenance documents
** Approval of QA release documents
** Responsible for Finished Product release
** Handling of Return Goods
** Handling of Recalls
** Monitoring of pest control activities
** Ensure effective functioning of the Quality Management System (QMS)
** Evaluate all GMP related incidents for determining any potential impact on safety, identity, Purity and quality
** Approve retest dates and extension of retest periods
** Authorize to stop production to ensure resolution of potential quality issues.
** Team Management - Performance Goal Setting for team, Review team performance and provide feedback, coaching and counseling to ensure team effectiveness.
** Performed process validation for both API’s & Intermediates.
** Provided CAPA reports for both Domestic & International Customer audits-95 audits
** Compiled and submitted CMC Documents -21 & DMF-04
** I had Faced Drug control, ISO-22000, ISO 9001-2008, Halal & kosher audits.
** I am Secretary of EHS committee in this site since 2013 to till date.
Research Experience :
Organization : NiTza Biologically (p) Ltd HYDERABAD, Andhra Pradesh.
Duration July 2009 to April 2011.
Designation : Sr.
Scientific officer.
Key ResponsibilitiesinNiTza Biologicals (p) Ltd :
** Served as a technical resource person.
** Ensure the laboratories operations adhere to the elements of good lab practice, such as Lab documentation, methods of analysis i.e.STP’s SOP’s, verifiable training of analysts, and applicable standards of quality control and quality assurance.
** Ensure reliable and efficient laboratory operations, calibrations were done as per schedule.
** Manage those individuals responsible for lab operation, implement and manage test schedules.
** Maintenance of lab schedule, cGLP compliance.
** Training analysts on lab methods.
** Prepared technical documents such as reports, operating procedures, methods, and study protocols.
** Designing the work plan for the new research projects and preparing cost analysis of the research works.
** Responsible for advanced discovery research and developing new technology in the areas of interest to NiTza Biologicals.
** Guided the post graduate students of the life science as part of their fulfillment of master degree in different techniques of respective topics of different regions students in India and helped them in preparing the thesis of not less than 150 students.
** Training the staff as part of on job training on the techniques of Microbiology and biochemistry.
** Conducted workshop’s in Enzymology in and around A.P, MAHARASTRA, ODISA, and CHATISGARRH AND JARKHAND not less than 50 workshops.
Academics Experience :
Organization : D.N.R. Degree College and P.G Center. Bhimavaram.
West Godavari. A.P Duration : July 2002 –July 2009.
Designation : Head of the Department Biochemistry and Biotechnology.
** Department founder and H.O.D. for Biochemistry & later worked as in charge for Biotechnology Departments in D.N.R College since 2003 to 2009 in D.N.R. (Autonomous) Degree College, Bhimavaram. A.P.
** Chairperson for Board of Studies in Biochemistry & Biotechnology Departments for the years 2006 to 2009 in D.N.R. College.
** Worked as practical examiner for autonomous colleges from 2003-2009.
** Worked as Deputy Chief Superintend for Intermediate exams from 2008-2009.
** Worked as core committee member for NAAC accreditation in the year 2005.
** Worked as Life science coordinator for the years 2005-2009
** Worked as Admission committee Secretary from 2007-2009.
** Served as staff Secretary 2007-2009
Organization : Ritam’s Degree College and P.G Center. Tanuku
West Godavari. A.P Duration : June 2001 –April 2002.
Designation : Lecturer in Department of Biotechnology
** Worked as Lecturer for both Post graduation and Degree Biochemistry.
** Worked as internal examiner for the P.G and Degree Practical examinations.
Educational Qualification :
M.Sc., Biochemistry from Andhra University affiliated college RITAMS Tanuku West Godavari, A.P (May2001/69%)
Strengths :
** Very flexible and adaptable to change.
** Responsible, operate with integrity and team work.
** Learning attitude and logical approach.
** Computer literacy skills in programs that applicable to role, solid written and Verbal Communication skills.
Technical Skills :
Computing skills : MS Windows 7 Excel
Packages :MS Office 2003 and MS Office 2007
Personal Details :
Date of Birth : 14.08.1975
Languages’ known : Telugu, English& Hindi.V.Madhava Rao
Mail : madhu.biochem AT gmail.com
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