Quality Assurance Team Leader
Resume:
CURRICULUM VITAE
K. BALAJI KOTESWARA RAO
******.**********@*****.***
Mobile : 837-***-****,
Career Objective:
Aim to be associated with a Progressive organization that gives me
the scope to share my knowledge and skills in accordance with the latest
trends and be a part of team that dynamically works towards the growth of
organization and gives the satisfaction thereof.
Education Summary:
M. Sc. (Microbiology)
B. Sc. (Microbiology, Zoology & Chemistry)
Total Industrial experience: Having 10+ Yrs
Current Job Experience:
A. Duration: November-2011 to till date.
Designation: Team Leader
> Hospira Healthcare India Pvt. Ltd, Green Field project (Sterile
formulation plant), Visakhapatnam.
B. Duration: November-2010 to November-2011.
Designation: Sr. Executive (E-3)
> Aurobindo pharma LTD, Unit-VI, Hyderabad is manufacturing
Cephalosporin Based Sterile Active Pharma Ingredients,
Injections & formulation and oral solids. An US-FDA approved
company.
C. Duration: July - 2009 to Nov-2010.
Designation: Group leader
> Vimta Labs Ltd, Hyderabad, is contract research and testing
organization.
Previous Job Experience
D. Duration: April-06 to July-2009.
Designation: Executive - Microbiologist.
> Aurobindo pharma LTD, Unit-VI, Hyderabad is manufacturing
Cephalosporin Based Sterile Active Pharma Ingredients,
Injections & formulation and oral solids. An US-FDA approved
company.
E. Duration: Apr-04 to March-06
Ashco Analytical services, Hyderabad an NABL approved company.
Designation: Sr. Microbiologist.
F. Duration: Apr-03 to March-04
> Qualicare Pharmaceuticals (Formulation Unit), Bollaram, HYD.
Job Responsibilities In Hospira Healthcare India Pvt Ltd.,
> Leading 10 member's team.
> Supervise the daily activities of Quality control functional
groups and set group priorities to ensure timelines are met
leads a diverse group and ensure collaboration of own team with
other functions.
> Internal audits & Audit compliance.
> Preparation and updation of documentation (SOPs, STPs,
Specifications, GTP and Protocols) related to Microbiology
department.
> Handling of out of specifications (OOS) and Queries.
> Joint responsible with Quality Assurance for all the
investigation and corrective, preventive actions incase of out
of trend results, out of specification results.
> IQ, OQ and PQ of new instruments.
> Calibration & Validation of microbiology lab instruments.
> Verification of Documentation for all routine analysis,
validations and
calibration as per regulatory requirements.
> To train departmental personnel and assigning the job
responsibilities to new joined persons.
> Handling regulatory queries related to sterile assurance
validations from regulatory bodies.
> Handling of exceptions
> Execution of the periodic calibration and performance
verification of laboratory equipments.
> Ensure the integrity of all records and data as applicable.
Validation/ Performance verification:
> Validation and efficiency of various disinfectants.
> Validation of water system.
> Aseptic Media fill.
> Sterility test method validation.
> HVAC qualification.
> Incubators, Freezers and Refrigerator.
> Endotoxin method validation.
> Personnel qualification.
> Analyst qualification.
> Power failure study.
> TOC Validation.
> Betalactamase validation.
> Pet and AET method validation.
> MLT method validation.
> Neutralizer validation.
Instrument Handled:
> Air Sampler.
> Liquid bond Particle Analyzer.
> Steri test Compact and Equinox pump for sterility testing.
> Non Viable Particle counter.
> BIOMERIUEX.
> Machine fabric Autoclave (Double door).
> Previ color gram stain system
> BBL crystal Auto reader
> Maldi-Toff (Rapid Microbial Identification system)
> ChemScan RDI (Rapid Microbial enumeration System)
Documentation:
> Documentation and Audit preparation for WHO, MHRA, MCC, GCC, EDQM,
GSK, TGA, ANVISA and USFDA.
> Preparation of SOPs, GTPs, STPs and specifications.
Achievement:
> A team leader for USFDA Audit Preparation held on May 2007 and
Dec 2010 at Aurobindo pharma LTD.
> A team leader for USFDA Audit Preparation held on June-2010
Vimta Labs Ltd.
> A team leader for TGA Audit Preparation held on April 2011 at
Aurobindo pharma LTD.
> A team leader for EDQM Audit Preparation held on December 2010
at Aurobindo pharma LTD.
> A team leader for GCC Audit Preparation held on Feb- 2009 at
Aurobindo pharma LTD.
> Actively participated in regulatory audits like ANVISA, MCC,
MHRA, Indonesia, WHO, ISO & GSK, Pfizer.
> A Group leader for NABL Audit Preparation at Ashco Analytical
Services and VIMTA labs.
Strengths:
> Possess good communication skills and ability to work in a team
as well as individually.
> Ability to lead and coordinate the team with good planning
skills.
> Ability to work under pressure, stress, and meet dead lines.
> Ability to work in a team with high level of involvement.
Personal profile:
Name : K.BALAJI KOTESWARA RAO.
Father's Name : K.K.L.V. PRASADA RAO.
Date of birth : 13-11-1979.
Gender : Male.
Marital Status : Married.
Languages known : English, Telugu & Hindi.
Contact Address : H.No:26-16-7/1,
Chaitanya Nagar,
Near RK Hospital,
Gajuwaka,
Visakhapatnam,
Andhra Pradesh.
(K.B.K.RAO)
Contact this candidate