Quality Control Management

VASAVI DASARI

Mobile: 732-***-**** E-Mail: **************@*****.***

** ****** *****, ** ** Kus, NJ - 07423

QUALITY CONTROL PROFESSIONAL

With proven track record of Quality control expertise in bacterial vaccines (more than seven years), seeking a challenging role that provides me an opportunity to explore and be part of a team that dynamically works towards the growth of the organization. Excellent ability to coordinate work and well organized to handle and prioritize multiple tasks. Attention to detail with problem solving capabilities. Flexible and Self-motivated to work with cross functional teams.

Green card holder, authorized to work in USA.

AREAS OF EXPERTISE

GLP, CGMP Bio Safety

Protocols, SOP ICH, WHO guidelines

Analytical Method Validations Tech transfer

Change Control Management Deviations, OOS

Document Management Reference Standards

In-vivo testing of Bacterial Vaccines Control Charts

Cell culture (Vero cells) Gap Analysis

HPLC (Empower software) Internal Auditor

EDUCATINAL QUALIFICATIONS & CERTIFICATIONS

Master of Technology in Biotechnology (Masters) from Acharya Nagarjuna University, India: 2003 – 2005

Master of Science in Biotechnology (Masters) from University of Madras, India: 2001 – 2003

Regulatory Affairs Certificate Course from RAPS Online University, USA: 2015

Diploma in Pharmacovigilance from Med varsity, India: 2013

PROFESSIONAL EXPERIENCE

SHANTHA BIOTECHNICS A SANOFI COMPANY, HYDERABAD, INDIA: Sep 2006 to Oct 2013

A WHO Pre-qualified and ISO 9001: 2000 Certified Organization and leading manufacturer of vaccines & biologics

Positions held: Senior Officer Quality Control: Apr 2010 to Oct 2013

Officer Quality Control: Apr 2009 to Mar 2010

Analyst Quality Control: Apr 2008 to Mar 2009

Analyst Trainee: Sep 2006 to Mar 2008

Key Responsibilities:

Supervision, planning and execution of Invivo (Safety and Potency tests) tests for Bacterial vaccines (D,T,P, Hep-and HIB group of vaccines) in GLP environment as per Pharmacopeia and WHO guidelines.

Adept in executing and monitoring various quality control tests (Invitro and Invivo) on In-process and Bulk bacterial vaccines and therapeutics.

Preparation and review of standard operating procedures, standard testing procedures and study protocols/reports.

Handling and Review of change controls, review and investigation of deviations, out of specifications, and Invalidities.

Trending of data and review as per regulatory the requirements. Preparation and review of batch records (QC part) for submission to Central Research Institute, Kasauli, India ( Department of Health and Family welfare)

Coordinating cGMP, GLP trainings with Quality assurance to ensure everyone is appropriately trained.

Support investigation/ Regulatory teams to determine root cause and corrective and preventive actions that ensure product quality and compliance.

Participated in method transfers and validation activities for Insuman formulations (Basal, Comb25 and Rapid)

Participated as a co-auditor for internal GMP audits (Inter departmental Audits).

Biosafety coordinator for Quality control department.

Planning and execution of Analytical Method validations for Bacterial vaccines as per ICH regulations.

Establishment and Qualification of internal reference standards and Controlled maintenance of Reference materials.

Preparation of Protocols and Reports for CPCSEA and IAEC.

Ensuring Quality Documentation practices as per QDMS.

Notable Achievements:

Demonstrated the suitability of different strains of mice for Tetanus and Pertussis antigens.

Successfully executed Invivo and Invitro tests for Shan 5 toxicology and clinical trial batches.

Established and calibrated tetanus and diphtheria challenge toxins and assigned LD50 units.

Developed frozen challenge suspension for pertussis challenge culture (18323).

Qualified liquid Internal Reference Standard (Invivo) and assigned potency units.

Successfully completed method transfers and method familiarizations for Insuman formulations with in the scheduled time lines.

Exposure control plans and work place risk assessments were kept in place for all the toxins and live materials present in the quality control lab to ensure Bio Safety.

MIC COLLEGE OF TECHNOLOGY, VIJAYAWADA, INDIA: Jul 2005 – Apr 2006

{A Ratified Institute by JNTU, Hyderabad}

Position: Assistant Professor/Lecturer

Department: B Tech Biotechnology (Course type: Bachelors)

Subjects: Immunology, Bioprocess engineering, Environmental biotechnology, Fermentation technology

TECHNICAL CERTIFICATIONS

Participated in work shop on Pharmacovigilance conducted by Med varsity and Viji Medsafe, India.2013

Certificate for the training program on Current Good Manufacturing Practices for Biologicals held at site in Shantha Biotechnics Limited during June 2007 to December 2007.

Participated in Training cum workshop on “vaccines production & testing’’ by DBA, UK.

Undergone one week Intensive course in Animal tissue culture, Stem cells and their applications at Sri Raghavendra Biotechnologies Pvt.LTD in Bangalore from Oct 14th 2004 to Oct 20th 2004.

ADDITIONAL INFORMATION

Computer Literacy: MS word, Excel and Power point

Working knowledge on SAP

Coordinating activities like CAPEX, OPEX, LRP calculations, Costing / Budget etc.

Member of Lean management from Quality control Department.

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