Quality Assurance Manager
Resume:
RESUME
S.SACHIN
E-mail: ***************@*****.***
CAREER OBJECTIVE:
To work in a challenging environment and give my best for organization is my commitment.
“Concept of Zero Error” is my prime goal. My ultimate goal is to grow with the organization.
STRENGTHS:
Tireless learning, an extremely logical bent of mind, undying pursuit of the goal, sound technical knowledge, stupendous communication skills and good problem solving capability would make for an ideal combination in the field.
EDUCATION DETAILS:
M.Sc (Microbiology) with 60% of marks from (Osmania University, Hyderabad, AP, India). (2005-2007)
B.Sc (Microbiology) With 73 % of marks from M.N.R. Degree College, (Osmania University, Hyderabad, AP, India) (2001-2004)
P.G Diploma in Bioinformatics & Chemo informatics
Form Bio Solution, Hyderabad (2004- 2005)
Intermediate( Bipc) with 60 % of marks from Samarth Jr College, Lathur, Maharastra, (2001)
S.S.C. from Board of Secondary Education in Siddhartha High School, Hyderabad with an aggregate of 59%.
SOFTWARE PROFICIENCY:
Office Automation : MS-Office 200/XP/2003
Operating Systems : Window’s 2000/XP, Ms-Dos
Language : C, C++, SQL,HTML
Web Technologies : Internet Concepts
Hardware : Troubleshooting, Maintenance
Contact Details:
Mobile:
Permanent Address:
S/o.S.Bahurang sadhu
D.No: 42-36,
Anjaiah Nagar,
Jagathgiri Gutta,
At Post Balanagar
HYDERABAD,
Pin-500037
ANDHRA PRADESH
HANDS ON EXPERIENCE: (Total 9 years plus Experience in QA/QC)
Present working with PAREXEL International (Hyderabad) as a GMP Auditor,
Quality Assurance since May-2012 till date.
PAREXEL is one of the largest biopharmaceutical outsourcing organizations in the world, providing a broad range of knowledge-based contract research, medical communication and consulting services to the worldwide pharmaceutical, biotechnology and medical device industries in order to accelerate time to- market, control development costs, reduce risk, and maximize return on investment. Its wholly owned subsidiary, Perceptive Informatics, Inc., develops and offers a portfolio of innovative information technology-based products and services that facilitate clinical drug development. Headquartered near Boston, MA, PAREXEL has a global footprint, with offices located throughout The Americas, Europe and Asia, and in Israel, South Africa, India, Australia and Japan.
Worked with UNIQUE BIOTECH LIMITED (Hyderabad) as a Sr.Executive
Quality Assurance since December-2009 to April-2012. (2.4 years)
Unique Biotech Limited is an ISO 9001:2008 & WHO GMP Certified Organization Manufacturing Pre and probiotics Formulations, is a Pioneering company in innovating Biotechnology for improved healthcare. It’s totally committed to the discovery, development &commercialization of innovating formulations and drugs for improved healthcare and is poised to grow in other related fields of enzyme, Biotherapeutics & Nutraceuticals.
Worked as an Jr.Executive QA/QC in Virchow biotech-kazipally, from June 2007 to December 2009. (2.7 years)
Virchow biotech is an ISO 9001:2000 Certified Organization Manufacturing Biotech Formulations, Dietary Supplements, injectables, Ointments, Probiotics.
Work Experience
I.Organisation: PAREXEL International, Hyderabad (A.P)
Designation: GMP Auditor-I Quality Assurance.
Plan, conduct, report and follow-up of QA audits under the supervision of the line manager to ensure compliance to applicable regulations, guidelines, SOPs and appropriate PAREXEL processes and study requirements. Acquire knowledge of domestic and international auditing and GxP requirements and developments. Become familiar with the training courses prepared by the RRC group on QA and GxP for presentation internally and externally. Develop a good knowledge of SOPs and promote SOP compliance within the company. Build, develop and maintain good working relationships with all internal customer groups. Liaising with the divisions of Project Management, Clinical Operations (GCP), Clinical Logistics Services, Procurement and Quality Management
II.Organisation: Unique Biotech Limited, Hyderabad (A.P)
Designation: Sr.Quality Assurance.
Responsible for all QA Documents including all Master Documents, Master Formulas, BMR’s, Site Master File, SOP’s, Validation Protocols, Audit Report etc.
To co-ordinate with HR for planning & implementation of training for employees on General and on SOP’s after approval or as and when required, and it’s Effectiveness Evaluation.
Handling of Consumer/ Customer Market Complaints, Deviations, OOS, Change Controls.
To perform approval activities of line clearance process and ensure the process is followed as per standards.
To ensure online documentation during production and packing activities.
Pre Dispatch Quality Audit of Finished Goods.
Dispatch of Finished Product and review of COA prior to release.
Preparation, Issuance, retrieval of BMR’s & BPR’s and their Archival.
Review of Analytical/Inspection records of Bulk and Finished product, Raw and Packing Materials.
Execution of Process Validation Activities.
Preparation of Annual Product Review.
Giving feedback to Quality Manager & Non conformances regarding RM,PM and Finished Product and taken the CAPA ( Corrective and Preventive Action)
Art work review and approval for loan license parties.
Well aware of all calibration activities related to QA, QC and Maintenance Departments.
Well aware of filter integrity test like Pressure Drop test, Diffusion test, Bubble point test and water Intrusion test/water flow test.
TECHNIQUES KNOWN:
Preparation of Microbiological media.
Isolation and identification of bacteria, fungi from any source.
Antibiotics Sensitivity by Kirby’s bauer method
Environmental Monitoring.
Test for sterility.
Microbial Limit Test.
Test for Bacterial Endotoxin
Microbial Analysis of purified water and water for injection.
ELISA
ABBOTT AXSYM SYSTEM
TRANING PROGRAM ATTENDED:
Participated in One day Workshop on ISO 9001:2008 & one day Workshop on ISO 9001:2008 QMS Audit Programme by Mr.S.R Choda from PQMS.
AUDITS FACED:
WHO GMP Audit.(2009)
ISO9001:2008 Audit (2009)
Kosher audit (2009)
HAS (Health Sciences Authority)- Singapore (2011)
ANVISA ( National Health Surveillance Agency)- Brazil (2012
ANMAT ((National Administration of Drugs, Food and Medical Technology) Argentinean (2012)
Supplier audits (Multiple & single supplier) (world) (China, South Korea, Thailand, Hong Kong, Singapore, Latin America (Chile, Brazil), Malaysia etc.
PERSONEL DETAILS:
Date Of Birth: 12.04.1983
Marital Status: Married
Father’s Name: S.Bahurang sadhu
Nationality: Indian
Languages Known: English, Hindi, Telugu, Marathi, Kannada & Konkani.
DECLARATION:
I here by declare that the information given above is genuine to the best of my knowledge and brief and if you give an opportunity to work in your organization, I will put my best efforts.
Place: Hyderabad. (S.SACHIN)
Date:
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