Manager Quality
Resume:
K. PRANEETHA
Versatile, high-energy professional, offering dynamic career in Pharma Quality Operations; scaling new heights of success with hard work & dedication and leaving a mark of excellence on each step
Location Preference: Bangalore
**************@*****.***
Bangalore
PROFILE SUMMARY
Result-oriented professional with over 12 years of excellence in Quality Control in Pharma Industry and implementing quality mechanisms to deliver desired output within India
Expertise in managing all microbiological related activities like Sterilization, Preparation of media, Growth Promotion for media, Culture maintenance, Media Disposal, Calibration and Validation of Equipment, Qualification/ Verification activity, Cleaning and fumigation of microbiology laboratory, Identification of water and environment isolates Intimating the out of specification results to the Head / Concerned Area to maintain the Microbiological data as per requirement of Quality System Experienced in driving QMS/QC Activities-OOS, Deviation, Change Control, Risk Assessment, Investigations, RCA, Audits, Equipment calibration & validation on the shop floor for ensuring adherence to GMP and Regulatory Compliance
Ensuring effective trainings & evaluation of technical SOPs to each QC personnel for quality output
Competent in monitoring the overall functioning of Quality control; identifying improvement areas with focus on profitability & customer satisfaction by ensuring optimal utilization of resources Successfully implemented quality standards and techniques and attained significant cost savings; excellence in analyzing existing processes & alleviating loopholes to execute measures for minimizing scrap or rejections Hands-on with various equipment such as Autoclave, Incubator, Laminar Air Flow, Colony counter, Air sampler & Microscope and so on Managed execution of QA and QC activities like transfers of analytical methods, validation analytical methods and their regulatory submissions, evaluation of pharmacopoeia method against in-house developed methods & routine release analysis in Quality Control Laboratory for formulation plant and Nutritional Business
Implemented Statistical Process Control (SPC), monitored-products quality control performance tests to verify instrument values with respective standards, in- house standards and manually
Exhibited tenacity and creativity in problem-solving with a proven record of innovating profitable solutions to complex problems; capable to take charge, set objectives, and drive results that bring financial gains CORE COMPETENCIES
Quality Control/Quality Assurance
Reporting/ Quality Compliance
Analytical Method Validations
Raw Material Testing & Validation
Process Improvements
Cost Optimization
Total Quality Management
Pharma Regulatory Compliance
Testing & Product Certification
Reports and Documentation
Process & Cleaning Validation
Team Management & Leadership
EDUCATION
M.Sc.(Applied Microbiology) from Sri
Padmavathi Mahila University, Tirupathi,
Andhra Pradesh in 2007 with aggregate 60%
B.Sc. (Biotechnology) from K.V.R. Women’s
College, Kurnool, Andhra Pradesh in 2004 with
aggregate 59.8%
Diploma in Pharmacy from Govt. Polytechnic
College for Women, Hindupur, Andhra Pradesh
in 2000 with aggregate 63%
CAREER TIMELINE
Nov’07-Jul’09
Jan’10-Jun’12
Jun’12-Feb’14
Mar’14-Apr’17
May’17-Sep’19
Dec’19-Jun’20
Falma Labs
Pvt. Ltd.
Medreich Ltd.
Geltec Pvt. Ltd. Micro Labs Ltd. Emcure
Pharmaceuticals
Ltd.
Biocon Ltd.
(Small
molecules
AREAS OF EXPERTISE
Water Testing: Routine analysis of Potable Water, Purified Water for estimation of Total Viable Count and Pathogens Media preparation: Regular procurement, preparation, sterilization, storage and utilization of media & growth promotion testing of media
Microbial Limit Test: Analysis of Raw materials, Finished products, Primary Packing Material etc., as per USP, BP, IP harmonized method
Maintenance of Microbial Cultures: Procurement, sub culturing and maintenance of cultures Environmental monitoring: Routing monitoring of controlled environments by Passive & Active air sampling Validation: Validation of Autoclave (Heat penetration and Heat distribution studies) Method Validation: Suitability of the counting method in the presence of product for various Raw materials and Finished Products Audit participation: Successfully faced MHRA, TGA, WHO, MYLAN, SANDOZ, GSK, PFIZER & USFDA etc. WORK EXPERIENCE
Dec’19-Jun’20 with Biocon Ltd. (Small molecules), Bangalore as an Assistant Manager May’17-Sep’19 Emcure Pharmaceuticals Ltd., Pune as Assistant Manager QC- Microbiology Mar’14-Apr’17 with Micro Labs Ltd., Hosur
Growth Path/Deputation:
Mar’14-May’15: Analyst Sr. Executive
May’15-Jan’17: Team leader Sr. Executive QC- Microbiology Jan’17-Apr’17: Assist. Manager-QC – Microbiology
Jun’12-Feb’14 with Geltec Pvt Ltd. Bangalore as Sr. Executive Microbiologist Jan’10-Jun’12 with Medreich Ltd., Bangalore, as Officer Microbiologist Nov’07-Jul’09 with Falma Labs Pvt. Ltd., Bangalore as a QC Microbiologist Role Across Career:
Monitored all microbiology related QC functions, the entire range of finished products in compliance with quality plan to verify the conformance of the product
Supervised Pharma QA & QC Process development, regulatory, project management and warehouse teams to deliver the analytical needs of commercial and new molecule validations successfully and timely Reviewed Analytical Reports & improved quality standards in the organization by implementation of new processes Executed cleaning activity & microbiological activities in the department Supervised the preparation and review of general, operation, calibration & cleaning SOP’s Imparted all necessary GMP/SOP technical trainings to the microbiologists Developed microbiological analytical methods for MLT and other microbiological techniques Prepared, reviewed and executed various methods of validation protocols and other non-routine validation protocols Assisted in:
o Preparation of qualification protocols for microbiology Instruments/Equipment o Identification of training needs (TNI) to microbiologists Selected appropriate vendors for equipment’s, cultures and media procurements Updated the existing SOP’s as per current Pharmacopoeial requirements Executed DQ, IQ, OQ, PQ of QC microbiology Instruments/Equipment’s Reviewed the microbiology related tested data pertaining to raw material, finished products, environmental monitoring, water etc. Ensured:
o All the instruments and equipments in the microbiology section are calibrated as per the schedule o GLP compliance in microbiology laboratory
Managed change controls through track-wise system, deviations, excursion reports and CAPA’s Acted as department level training coordinator through e-LMS system (electronic learning management system) i.e initiation of trainings through e-LMS
Reviewed and maintained media preparation records, GPT records, usage logs of instrument/equipment sterilization records etc. PERSONAL DETAILS
Date of Birth: 9th June 1980
Languages Known: English, Telugu & Kannada
Address: House No.137, first floor, Crown Orchid Apartment, Near Narayana, Hrudayalaya, Hosur Road, Chandapura, Bangalore-560089
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