Rakesh Bijalwan Sr.

Executive-QA/QC India Glycols Limited

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To, Personnel Manager, _________________________ _________________________

Subject: Application for Suitable post in Quality Assurance/Quality Control Department Sir, I would like to apply myself for suitable post in Quality Assurance department in your esteemed organization; I am enclosing my detailed biodata herewith for your kind consideration and perusal. If you find me suitable for the same allow me to face an interview. I promise, I will work to best of my ability for achieving the goal of organization and betterment of my career. Yours truly, Rakesh Bijalwan Date:

Rakesh Bijalwan Sr. Executive-QA/QC India Glycols Limited CURRICULUM VITAE OBJECTIVE:

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To learn current and relevant technology from your vast experience and it combination With my acumen and sound knowledge acquired over the years to develop effective skills to maximize individual organization productivity. To embark upon a career, which provides me with an opportunity to develop and perform in the field of pharmaceuticals industry. To be a part of the team and to establish myself as leading professional in the field.

INDUSTRIAL EXPERIENCE:
Working with India Glycols Limited, Selaqui (Pharma Unit) as Sr. Executive QA from June-2010 to till date. As an Executive-QC/QA in M/s Ind-Swift laboratories limited, Samba (Jammu) from October-2008 to May-2010 As an Executive QC in M/s Vitalife Laboratories Limited(a Division of Arch Pharma Laboratories Limited from December-2007 to September-2008 As an Officer-QC in M/s Saurav Chemicals Ltd., Dera bassi (Pb.) from April 2005 to December 2007. As a Tr. & Sr.Q.C.Chemist in M/s Surya Pharmaceutical Ltd., Banur (Pb.) from July 2001 to April 2005.

JOB DESCRIPTION: Quality Control :

Review of all data of finished Goods/Raw material and Preparation AMC & Calibration schedule for Instruments/Equipment. Stability studies of finished goods & holding time study of Intermediates & Key Raw materials IQ/OQ/PQ of Instruments. Works under Regulatory Requirements. Analysis of release or rejected of Raw Material, Intermediate and packaging material. Preparation of Standard Operating Procedure, Standard Testing Procedure, Product Specification, testing method as per IP/BP/USP and market norms. Maintaining and reviewing the all QC documents as per USFDA, cGMP requirement. Calibration and Review of all calibration data of Lab Instruments. Reviewing all Analytical Protocol/ Raw data sheet. Column management and its performance.

Rakesh Bijalwan Sr. Executive-QA/QC India Glycols Limited

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Review of reports of quality control department and related records of working standard & reference standard and calibration reports of instruments

Quality Assurance:
Overall monitoring of activities of quality control & quality assurance department. Complete Sampling of Raw Materials/Packing Materials, Semi Finished products and finished products. Documentation according to cGMP. Issuance and Reviewing of BPCR/BMR. Preparation and distribution of SOP.(QC/QA) Qualification of Air Handling Units.(HVAC System) Qualification of Balance. Carry out Internal Audits for Regulatory Compliances. Process Validation Protocols and Process Validation Reports. Preparation of Stability Protocols and Reports Preparation of Analytical Validation protocols for API. Preparation of Validation Master Plan and Site Master File. Water System Validation Knowledge about Regulatory Requirements. Preparation and looking after all IQ / OQ / PQ Procedures and validation protocol of machineries. Knowledge about Cleaning Validation. Knowledge of SAP System. All activities of Quality assurance & Quality Control through SAP system. Execution of Training Program.

INSTRUMENT HANDLED
HPLC Shimadzu- LC-2010 AHT & Shimadzu-LC-2010 CHT Auto Injector with LC-Solution Software, Agilent-1100, 1200 Series Auto Injector with Ceritycomm & Chemstation Software, Waters-2487 with Breeze Software, Shimadzu 2010 PD with LC Solution Software, Waters-486 with Maxima-820 Software, Waters Alliance Model with Empower Software, Dionex with Chromleon software GC (Netal, Nucon-5765 with Winchrom Software, Chemito-8610 Ht with Chemitochrom Software, Agilent-7694 Headspace with ceritycomm Software, Agilent6890N & Agilent 6850 Series with Certycomm & Chemstation software) Perkin Elmer with Totalchrom Navigator Software. Karl Fischer Titrator (Veego Matic, Electonics India, Mettler Toledo-DL-31, Labindia) Auto Titrator (Metrohm-702, SM Titrino, Mettler DL-25) Polarimeter (Rudolf Digital, perkin elmer-341) BD Apparatus (Secor, Kumar) UV Spectrophotometer (Simadzu-UV-1700S, Cintra-1601, Perkin Elmer-Lambda 25)

Rakesh Bijalwan Sr. Executive-QA/QC India Glycols Limited

Particlae size Analyzer (Malvern)

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EDUCATIONAL QUALIFICATION:

B.Sc. from Lucknow University with 2nd div. in 2001.

TECHNICAL QUALIFICATION:
Approved Technical person in Instruments & Chemical (Quality control) from FDA (J&K).

COMPUTER SKILLS:
CIC (certificate in computing) from IGNOU.

TRAINING ATTENDED:
QA concept by Dr. G.L. Jain (Team Member of WHO-GMP Auditors) Handling of Deviation & CAPA by Dr. Sumanth Baukhandi (Director Pharma Institute of GMP) Change Control Management by Dr. Sumanth Baukhandi (Director Pharma Institute of GMP) Risk Management by Dr. Sumanth Baukhandi (Director Pharma Institute of GMP) Statistical Quality Control and Statistical Product Control by Dr. Sumanth Baukhandi (Director Pharma Institute of GMP) Current Trends in Stability Study by Dr. Sumanth Baukhandi (Director Pharma Institute of GMP) Preparation of Drug Master File by Dr. Sumanth Baukhandi (Director Pharma Institute of GMP)

AUDIT FACED:
Successfully faced ISO Audit in Ind-Swift laboratories Limited & India Glycols Limited. Successfully faced EDQM audit in M/s Saurav chemicals Limited Pharma. Successfully faced USFDA audit in M/S Vitalife laboratories Limited(A division of Arch Pharmalabs).

Rakesh Bijalwan Sr. Executive-QA/QC India Glycols Limited

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PERSONNEL DETAILS:
Fathers Name: Date of Birth: Permanent Address: Sh. Ram Prasad Bijalwan 10th December, 1981 S/O- Sh. Ram Prasad Bijalwan House No- 109 Village & P.O- Nathuwala Distt- Dehradun-248001 Uttarakhand 09627229152 rkshbijalwan470@gmail.com Rakesh.bijalwan@rediffmail.com Salary Drawn: 4.2 Lac/year Expected Salary: Negotiable

Contact No.: E-Mail Address:

Date: Place:

_____________________ Rakesh Bijalwan