5my QA Resume-jv M.sc | Verification And Validation | Freeze Drying

CURRICULUM VITAE J.VENKANNA, H.No: 13-9-1/2/37/2, Ganeshnagar, Borabanda, Hyderabad – 500018.

Ph: 9292701689 Email: venkanna_jutthika2000@yahoo.com

OBJECTIVE: To pursue a challenging and innovate carrier in the emerging field by being associated with a progressive organization, use my education and knowledge. Prove myself as one among the best and asset for the organization. EDUCATIONAL QUALIFICATION: • Master of Arts ( M.A- English literature ) perusing from Acharya Nagarjuna University from 2008 – in distance mode. • Master of Science (Analytical Chemistry ) 57% from Acharya Nagarjuna University from 2006 – 2007 in distance mode. • Bachelor of Science (B.Z.C ) 67% from Andhra University from 2002 – 2005. • Intermediate(Bi.P.C)54.4% from Board of Intermediate education from 1999 – 2001. • S.S.C 68% from Board of Secondary Education in March – 1999. TECHNICAL SKILLS: • Os − Windows 98/2000/2003/XP • MS – Office • Adobe Photoshop ACHIEVEMENTS: • Attend several GMP training programs. Periodically internal training programs conducted by external consultants with the latest development with cGMP. WORK EXPERIENCE:  Working as a QA Chemist for UNI SANKYO LTD, injectables in Unit-II in QA department from Oct 2006 to till date. RESPONSIBILITIES: • To ensure that product quality is secured all the time by control over production, QC, Stores, and Engineering dept. To ensure that work is going as for cGMP. • Issueing and follow up of BMR’s, BPR’s, Test / Analytical / protocols and Log Records to the respective departments. • Maintaining process records online along with daily documents. • Online monitoring of BMR/BPR completion & other related GMP records in production. • Collection of samples (product samples, WFI, purified water (DM water) and send them to QC for analysis. • Performing In-process quality checks in the departments during manufacturing and to give line clearances for the critical operations • Collection and Maintenance of Control Samples. • Monitoring and Execution of real time stability studies and Stability evaluations. • Management of Stability samples of new & existing products.. • Development, Implementation, Review and Verification of Standard Operating Procedures, Analytical Protocols and Log Records. Page 1 of 3

CURRICULUM VITAE Preparation of training materials and presentations. • Review of process and batch data to provide appropriate OQ and PQ acceptance criteria. • Review and verification of completed BMR’s / BPR’s received from production prior to release. • Preparation & Issue of PRS’s. • Monitoring of personnel hygiene, cleaning & disinfections of areas with respect to Production, Stores, QC lab, Bio lab & Microbiology lab. • Verification and approvals for Art works, Shade cards. • Monitoring of storage practices for RM / PM / IP& FP for its compliance. • Simplification and Redesign of documents. • Execution and monitoring of GLP, GMP and cGMP guidelines in shop floor. • Corrective and Preventive Action (CAPA), • Quality Management and Quality Systems Development. • Visit to the internal audits in the divisional manufacturing sites for facility/quality and GMP Compliance. • Monitoring validity periods for equipment calibrations / validations / volumetric solutions / standard weights / working standards in production / stores & QC departments. • Performing validations periodically, Equipments validation, Water system validation (Distilled water, DM water and Steam), Product validations, Cleaning validation and Process validations. • Preparation of master schedules for calibration, validation, stability studies samples collection & market surveillance programs. • Plan for Internal self inspections of all departments as per Self Inspection Schedules. M/S UNI SANKYO LTD, Hyderabad, a joint venture with Dhiichi sankyo ltd-japan. Company Profile: It is having WHO & ISO 90001 2000 Approved injectable unit, formulation, a pilot scale bulk chemicals unit, Biotech plant and R&D situated at Gaganpahad, Hyderabad. (Our UNIT-II involved in the formulation of Small volume parentarals).  Worked as a Technical Assistant for UNI SANKYO LTD, Injectables (formulation division) in production department from 5th Oct-2005 to Oct 2006. EQUIPMENTS HANDLED: • Semi Automatic jet ampoule washing M/c. • Dry Heat Sterilizer. • Autoclave (steam sterilizer). • M.E.D.S. (distillation plant). • Ampoule filling sealing M/c. • Lyophilizer (freeze dryer). • Optical testing M/c. • Ample Sticker Labeling M/c. • R.O & D.M plants. RESPONSIBILITIES: • Preparation of various production related documents. Page 2 of 3 •

CURRICULUM VITAE • • • • • • • Maintaining process records in online along with daily documents. Preparation and Implementation of S.O.P’s. Effective Cleaning and Disinfection of Sterile and Non-sterile areas. Sterilizations. Compounding (batch mixing), filtration & Liquid filling (both liquid oil injectable ptoducts and Freeze-dried injectable products) Freeze drying (lyophilization). Water purification by RO and Ion exchange techniques.

SKILLS: • Knowledge of US FDA regulations. • Quality System Inspection Techniques (QSIT). • Quality System Regulations (QSR). • Knowledge of schedules-M,U&T • GMP guidelines. • WHO guidelines. STRENGTHS: • Effective communication skills reliable. • Hardworking and quick learning. • Ability to manage multiple tasks simultaneously. • Good level of self confidence. PERSONAL DETAILS: Name Father name Date of Birth Marital status Nationality Religion Languages known Permanent address : : : : : : : :

Venkata Ramarao 20th August 1983 single Indian Hindu Telugu, English & Hindi. J. Venkanna, S/o. Venkata Ramarao, Satyanarayana nagar, Mulalanka ( post ), Kalidindi ( mandal ), Kaikaluru(TQ), Krishna ( Dist ), Pin – 521344.

DECLARATION: This is certify that the above mentioned information is true and genuine to the best of my knowledge. Date: Place: Hyderabad.

(J.VENKANNA) Page 3 of 3

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