Quality Assurance Management
Resume:
CURRICULUM VITAE
NAME: SEELAM. TIRUVENDRA
DEPARTMENT: QUALITY ASSURANCE
DESIGNATION: HEAD-QUALITY ASSURANCE
(CLINICAL, BIOANALYTICAL AND CLINICLA TRIALS)
DATE OF BIRTH: 20 OCT 1984
CONTACT : (H.P) +91-800*******
EMAIL- twhcmr@r.postjobfree.com
Email- twhcmr@r.postjobfree.com
M.Sc.with 5 years of experience in Quality Assurance Department in Clinical Research Organizations/Health Care/pharmaceuticals
Objective
I am now looking to build on my extensive range of technical skills within a suitably challenging role. I am keen to achieve further professional development. Which would give me an opportunity to update my knowledge and hard work to the growth of the organization.
Professional Profile
I am an enthusiastic and dedicated professional with 5 years of experience in Quality Assurance Department. Able to work on own initiative and as part of a team. Proven leadership skills involving managing, developing and motivating teams to achieve their objectives and problem solving skills. Dedicated to maintaining high quality standards.
Academic profile
1. Bachelor of Science -B .Sc (Biotechnology)
Passed with university with an aggregate of 60% of marks
University: Sri Venkateswara University, Tirupathi. A.P, INDIA.
Duration: 2001-2004 Year of completion: 2004.
2. Master of Science -M. Sc (Biotechnology)
Passed with university with an aggregate of 68% of marks
University: SRM Institute Of Science And Technology, Chennai. T.N,INDIA
Duration: 2004-2006 Year of completion: 2006.
3.Post Graduate Diploma in Bio-Informatics-PGDB
Passed with A grade
Institute –SISI: Small Industrial Service Institute, Chennai. T.N,INDIA
Year of completion: 2006.
4.Post Graduate Diploma in Computer Applications-PGDCA
Passed with A grade
Institute –ECIT-ECIL: Electronic Corporation Of India Limited, Tirupathi. A.P INDIA
Year of completion: 2004
Professional Experience:
Worked as a Bioanalytical QA Research Associate (Bioanalytical) in TRIDENT LIFE SCIENCES LIMITED
In the Department Of Clinical Pharmacology Unit and Bioanalytical Quality Assurance Department, at Miyapur, Hyderabad from May 2006 to January 2008. (CRO)
Worked as a Lead Auditor (Clinical and Bioanalytical Operations) in Quality Assurance Department for both clinical and bioanalytical in Huclin Research Limited from February 2008 to December 2008.(CRO)
Worked as a Manager (Clinical, Bioanalytical and Regulatory Affairs) Operations in Quality Assurance Department for both clinical and bioanalytical in Azidus Laboratories Limited from January 2009 to August 2009.(CRO)
Presently working as Head Quality Assurance (Clinical, Bioanalytical and Clinical trials) Operations in Azidus Laboratories Limited from August 2009 to till date (CRO).
Present Job Outline:
Overall management of Quality assurance and regulatory affairs department.
Responsible for over all external communications with the sponsor’s auditors and regulatory bodies.
Implement and manage the Quality System in line with Business strategy.
Responsible for Leading Quality Assurance Team (Bio analytical and Clinical and clinical trail team) and managing the QA operations, in order to ensure that- the all applicable regulatory requirements.
Define, develop, advise and ensure that the most effective quality assurance (QA) processes are operated within the organization.
Co-ordinate and guide the activities and functional of QA team to ensure all QA activities, including documentation control and auditing, are undertaken in a compliant and timely manner.
Drive the process of continuous improvement.
Responsible for organizing, conducting GCP and GLP clinical, Clinical trails and Bio analytical studies in process ,study specific audits and site audits reviewing of study data’s and generating reports.
Responsible for maintaining communications with regulatory agency and sponsor representatives regarding approvals and site inspection.
Responsible for communicating with regulatory bodies and obtaining major approval for organizations.
Responsible for document control system including validation reports, SOP's, methods, study protocols and reports
Responsible for providing staff training with GCP/GCLP and other regulatory and ISO standards as and when required.
Responsible for organizing, conducting on site Audits for ongoing Phase trails
Responsible for implementing NABL standard ISO 15189:2007 and communicating with NABL getting approval for In-house diagnostic laboratory.
Responsible for communicating with college of American pathologist (CAP) Implementing the system as per CAP requirement and getting major approval for In-House diagnostic laboratory.
Responsible for Identify non-conformances as per the company SOP’s polices and applicable regulatory requirements and provide suitable recommendations.
Responsible for Assuring that audit reports are completed in a timely manner by QA team and that audit results are communicated to auditees and management
Responsible for Ensuring suitable responses and corrective action plans provided by auditees.
Responsible for organizing and conducting vendor audits.
Responsible for reviewing of all clinical and Bio analytical SOP’s and as per regulatory requirements and authorizing of all departmental SOP’s
Responsible for preparation for facing all regulatory inspections and sponsor audits.
Responsible for maintaining and implementing quality systems as per ANVISA and UK-MHRA
Responsible for implementing organization facility as per Turkey MOH, UAE MOH, Israel MOH and Sudan MOH regulatory requirements to obtain their facility approval for the organization.
Responsible for preparation and communicating with regulatory bodies to obtain their facility approval for organization.
Responsible for Implementing applicable regulatory systems and ISO standards in the organization and Assure management of the compliance level
Promote and advance quality awareness throughout the Company.
Acting as a one of the key personnel in the growth of organization.
Technical Skills:
Preparation, Review and control of Standard Operating Procedures, policies and Manuals.
Reviewing of Validation reports and Bio-analytical reports in compliance with Companies SOPs, GLP, and applicable regulatory requirement
Reviewed more than 550 BA/BE studies (Raw data’s and final Report) and generated QA reports.
Reviewing of Clinical Raw Data forms CRF’s and final clinical report in compliance with Companies SOPs, , GCP and other applicable regulatory requirement.
Monitored and reviewed more than 60 clinical studies, generated QA reports.
Having Good experience conducting in auditing like System Audits Facility Audits and Study Based Audits in compliance with company SOP’s and other applicable regulatory requirements.
Lead and direct Team of QA personnel for conducting vendor audits and generated reports.
Hands on experience Verification and final review of bioequivalence submission reports as per specified guidelines.
Checking the compliance of study related activities to OECD, ICH-GCP/GLP, Sops and Protocols.
Hands on experience implementing Quality System in terms of Preparation of manuals, polices and maintaining the Quality standards as per ISO 9001 and ISMS 27001, ISO 10015 and ISO 14001 & 18001.
Training employees for Quality System and regulatory guidelines.
Reviewing documents related to Bio-analytical, clinical, Clinical Investigations and Pharmacokinetic & Statistical department.
Reviewing of Systems of various departments (Clinical, Clinical Investigations and Bio-analytical, Pharmacokinetic and Statistical and Method SOPs, Validation Protocol, Validation report and Bio-analytical reports in compliance with Companies SOPs, GLP, GCP and other specified applicable regulatory requirement.
Reviewing of study clinical study protocols as per guidelines before submitting to ethics committee. Reviewed more than 500 protocols.
Reviewing of randomization schedules, study concentration tables for Pharmacokinetic and Statistical Departments.
Reviewing and Verification of installation qualification/Operational qualifications/performance qualification
Documents and calibration records of various analytical instruments.
Hands on experience for preparation of -Quality manual – Training Manual – Safety manual, Bio Infection control safety Manual, Information security management safety manual, EHS manual ,OSHAS manual .
Plan and guiding of clinical and bio analytical QA team for their activities.
Reviewing of all reports like clinical report, statistical report bioanalytical report and summary reports.
Conducting the management review meetings to set up the goals and monitor the progress of the projects.
Managing the functions of GCP-GLP to assure B.A/B.E studies.
Coordinating and implementing applicable regulatory systems and communicating with regulatory bodies to obtain inspections from different regulatory bodies.
Hands on experience to review the pilot and pivotal studies reviewed more than 380 studies both pilot and pivotal both clinical and Bio analytical for various regulatory markets.
Minimum knowledge on LC-MS/MS and HPLC techniques.
Provide support for the documentation system.
Carry out periodic inspection and audit at bioanalytical unit of clinical pharmacology department operations as per SOP’s and regulatory guidelines to ensure the organization facility. .
Reviewing of all types of reports that is bioanalytical report, biostatics report, clinical reports and summary reports.
Having good knowledge on all guidelines ICH-GCP/GLP, FDA, ANVISA, MHRA, TURKEY, UAE, ASSEN country BA/BE guidelines.
Professional Credits.
Significant contribution for preparation design and development of SOPs for clinical research BA/BE studies.
Having Knowledge on preparation of CRFs, ICFs, Clinical forms & logs.
Implemented Quality Systems in Azidus Laboratories Limited As per all regulatory guidelines
Good expertise in reviewing of Clinical Proocols, ICF’s, CRFs, Clinical Final Report and other related documents and assisted the Quality Assurance unit.
Good expertise in reviewing of all Bio analytical documents like Method SOP, Method validation SOP, PMV,Validation Rawdata,Subject Sample Analysis Raw Data and Bioanalytical Report in compliance with company SOP’s.
Monitored more than 500 clinical studies and assured the protocol was followed and data was reported accurately.
Monitored and reviewed more than 60 clinical trail documents as per GCP guidelines.
Audited more than 40 sites for conducting clinical trails (pre qualification Audits)
Hands on experience to prepare and assist for documentation full process and implementation to ISO 9001:2008(QMS: Quality Management Systems).
Hands on experience to prepare and assist for documentation full process and implementation to ISO 27001:2005 (ISMS: Information Security Management Systems).
Hands on experience to prepare and assist for documentation full process and implementation to ISO 10015:2005 (Training Standard).
Hands on experience to prepare and assist for documentation full process and implementation to ISO 14001:2004 (EMS: Environmental Management Systems).
Hands on experience to prepare and assist for documentation full process and implementation to ISO 18001:1999 (OSHAS: Occupational Safety health Assessment Series).
Hands on experience to prepare and assist for documentation full process and implementation and communication to NABL for Obtaining NABL accreditation( ISO 15189:2007 (NABL)
Hands on experience to prepare and assist documentation and implementation and communicating to CAP for
Technical quires. Have good knowledge on obtaining CAP accreditation for in-house diagnostic laboratory.
Having good Knowledge for preparing and assist in compliance with UAE guidelines to obtain UAE MOH facility approval for CRO.
Having good Knowledge for preparing documentation and assist in compliance with Turkey guidelines to obtain Turkey MOH facility approval for CRO
Having good Knowledge for preparing documentation and assist and well familiar with ANVISA guidelines to face ANVISA accreditation for CRO.
Having good Knowledge for preparing documentation and assist in compliance with Turkey guidelines to obtain Sudan MOH facility approval for CRO
Having good Knowledge for preparing and assist CAP approval for independent clinical laboratory.
Well familiar with all procedures and submission of dossiers to obtain all facility approval for CRO, Turkey MOH, UAE MOH, Israel Authority Approval, and MHRA.
Audits Faced:
Audits conducted by various domestic as well as international sponsors for system and facility audits at Azidus Laboratories Limited.
Faced Audits for study specific audits by the sponsors
Faced various international sponsor audits
Successfully faced the FDA audit
Successfully faced ANVISA audit
Successfully faced an ISO 9001:2008 audit (QMS) for Azidus Laboratories Limited.
Successfully faced an ISO 27001:2005 audit(ISMS) for Azidus Laboratories Limited
Successfully faced an ISO 15189:2005 audit(NABL) for Azidus Laboratories Limited
Successfully faced an ISO 10015:1999 audit(Training Standard) for Azidus Laboratories Limited
Successfully faced an ISO 14001:2004 audit(EMS) for Azidus Laboratories Limited
Successfully faced an 18001:1999 audit(OSHAS) for Azidus Laboratories Limited
Successfully implemented CAP accreditation process for Clinical Laboratory(College Of American Pathologist) for Azidus Laboratories Limited
Successfully faced CAP Audit (College Of American Pathologist) audit for Azidus Laboratories Limited
Successfully faced an audit from NAFDAC Nigerian Audit for Azidus Laboratories Limited
Successfully faced an ISO 15189:2007 audit (NABL) for Azidus Laboratories Limited.
Successfully faced an ISO GHANA FDA audit for Azidus Laboratories Limited.
Successfully faced DCG(I) Audit for Azidus Laboratories Limited
Personnel Asset:
Reviewed more than 550 BA/BE and clinical studies and provided Audit Observations and generated reports.
Reviewed more than 30 clinical trail activities conducting at offsite facility and generated QA reports.
Hands on experience to conduct the audits like Facility, System, and Study Based Audits.
Having good contacts with regulatory bodies for updating regulatory requirements.
Planning and directing individual Team of personnel in various activities for timely completion of assigned projects.
Act as interface between operational team and sponsor team for timely submission of the projects.
Hosting various regulatory authorities during inspections.
Reporting to management about the need of the regulatory requirements along with the comparison of the in-
House system.
Minimum Knowledge on SAS PROGRAMMING SAS/BASE,SAS/MACROS.
Well familiar with all ISO standards.
Additionally performing as a SAFTEY OFFICER Role for the ISO Standards 14001 and 18001 compliance.
Well familiar with ISO 27001 standard ISMS to implementing information Security Management Systems with in the organization.
Trainings Attended /Certifications:
Attended training programme “GOOD LABORATORY PRACTICES” conducted in clinical pharmacology department at Trident Life Sciences Limited.
Attended the training programme “PRECAUTIONARY MEASURES ON SAFTEY ISSUES” conducted in clinical pharmacology department at Trident Life Sciences Limited.
Attended the training programme “BIO MEDICAL WASTE MANAGEMENT-HANDLING AND SAFE DISPOSABLE OPTIONS” conducted in clinical pharmacology department at Trident Life Sciences Limited.
Attended the training programme “COLD CHAIN MANAGEMENT-HANDLING AND SAFE TRANSPORT OF CLINICAL SAMPLES” conducted in clinical pharmacology department at Huclin Research Limited. Limited.
Attended the training programme “GOOD CLINICAL PRACTISE” conducted by INSTUITE OF PHARMOCOLOGY MADRAS MEDICAL COLLEGE-CHENNAI.
Attended the training programme “FIRE FIGHT AND SAFTEY” conducted by USHA FIRE SAFTEY at Azidus Laboratories Limited.
Attended the training programme “Handling Of LC-MS/MS” conducted by Agilent Technologies Limited at Azidus Laboratories Limited
Qualifications Hilights:
Knowledge in all areas of research including GCP, CDCSO, IRB protocol submissions, ANVISA, FDA guidelines.
Knowledge in all Regulatory guidelines Requirements like ANVISA, TURKEY, SUDAN,UAE,EUROPEAN, ISRAEL,CAP,NABL,(ISO 15189:2007) and ASSEN countries BA/BE guidelines.
Hands on experience to implement the ISO standards 9001:2008(QMS), 14001:2004 (EMS), 18001:2007 (OSHSA) ,10015( training standard),27001 (ISMS),NABL for diagnostic Lab and CAP accreditation for Diagnostic Laboratory.
Working as a management representative for the ISO 14001 and 18001.
Proven project team leader abilities with capacity to design, plan & implement ideas from conception through completion, able to manage multiple responsibilities without compromise to detail or quality.
Extensive knowledge in clinical research terminologies and pharmaceutical domains
Extensive knowledge in clinical data management and 21 CFR part 11 and EDC.
Outstanding interpersonal skills, equally comfortable community one-on-one or addressing large audiences
Technical profile:
Have an average speed on keyboard.
MS office literate.
Can prepare documents using MS word.
Can prepare presentations using MS power point
Competent in Internet surfing and emailing
Good Knowledge in using MS excels for data analysis.
Competent in searching for relevant and reliable articles and references and information on net.
Good Knowledge in preparing of Excel sheet’s for calculation of all BA parameters.
Personnel Information:
Name : S.Tiruvendra
Date of Birth : 20-OCT-1984
Fathers Name : S. Raghavaiah
Mothers Name : S. Rajakumari
Nationality : INDIAN
Languages Known : English, Telugu,Tamil,Hindi,
Native : Gudur (Nellore Dt.)
Presently Located : Chennai
PRESENT ADRESS PERMENENT ADRESS
S.TIRUVENDRA
C/O.C.SUDHAKAR
NO:35, KASTHRI BAI STREET
CORNITION NAGAR
CHENNAI-600021
TAMILNADU S.TIRUVENDRA
S/O.S.RAGHAVAIAH
D.NO:72/B, RAILWAY QUARTERS
NEAR SOUTH CABIN WEST
MALAVYA NAGAR
GUDUR,NELLORE (DISTRICT)-524102
ANDHARA PRADESH
INDIA
Declaration:
I hereby declare that the details furnished above are true to the best of my knowledge. I would truly prove myself and would sincerely serve my best for the growth of the organization.
Place: Tiruvendra.S
Date:
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