1) Ruturaj K Sutarsandhiya is seeking a challenging opportunity in pharmaceutical analytical development with a focus on method development, validation, and stability studies.
2) He has over 15 years of experience in method development, validation, and stability studies for drug products and substances. He has experience conducting in vitro bioequivalence studies.
3) His most recent role was as Manager I at Sun Pharmaceuticals, where he successfully completed over 150 method validations and was a key member of the organization.
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A detail-oriented, sincere and hardworking individual with a Master of Science and Over Fourteen years of GLP/GMP work experience
Expert in Audit trails review in Empower, Lab solutions, Tiamo and other softwares.
Experience in theoretical and practical knowledge in calibration, preventive maintenance, troubleshooting and problem solving of critical equipment like HPLC, GC, Auto Titrator,DR and UV-Spectrophotometer etc.
1. 1
SUTARSANDHIYA RUTURAJ KALIDAS
Residential
Address
: Flat No.C103, Prayosha Appartment, Opposite Gopinathji show room,
Near Brahama Kumari, Atladara, Vadodara. 390012
Permanent
Address
: At: Ghanad
Taluka: Lakhatar
District: Surendranagar
Vaya: Vana
363110.
Cell phone No. : +917573010650
e-mail : ruturaj143@gmail.com
Objective:
Seeking for a challenging opportunity in the field of Pharmaceutical industry in the core area of Analytical
method developments, method validations, Stability studies with focus on Team work where the path ends
with the success of the organization as well as individuals.
Professional Synopsis:
A dynamic professional since 2006 having experience in Method development, Method validation, Stability
studies in the field of drug products and drug substances as well as hands on experience to conduct the Invitro
BE study for ion exchange resins formulations.
Education Qualification:
1
)
Master of Science in chemistry from Sardar Patel University, Vallabh Vidhyanagar, Anand, Gujarat.
2
)
Bachelor of Science (Chemistry) from Sardar Patel University, Vallabh Vidhyanagar, Anand, Gujarat.
Job Profile:
1
)
Company Name: Sun pharmaceutical advance research center - Since January 2006
Department: R and D , Analytical Development department
Sub department: Method Development and Method validation
Job Title: Manager-I
Skills and Deliverables :
1) Able to use technical background to analyze processes and innovative development to
challenges with help of Sophisticated instruments like HPLC, GC, Dissolution, and UV
Specrophotometer.
2) Analytical Method development of API and various Formulations.
3) Analytical Method Validations of API and various Formulations.
2. 1
4) In vitro studies: An Invitro comparison of Test product with that of Reference product.
5) Pharma equivalence study (Multimedia dissolution study) of formulation and interpretation
for the equivalency of the formulation.
6) Strong communication and interpersonal skills; skilled in building effective teams to execute
project and maximize the results by managing the resources.
7) Successfully completed about 150 method validations covering Assay validation, related
substances validation, dissolution validation and CU validation as per USP / ICH guidelines.
Job responsibility:
1) Develop and validate analytical methods (mostly by HPLC) for active pharmaceutical
ingredients, excipients and dosage forms to be used in the analytical R&D laboratory for
routine analysis.
2) Preparation of method validation reports and method development reports.
3) Development and optimization of new and existing analytical methods for qualification,
release testing of products.
4) Perform and coordinate laboratory equipment qualifications, calibrations and preventative
maintenance programs as needed.
5) Provide training and guidance to laboratory analysts and group members aimed at developing
technical capabilities.
6) Ensure that procedures are technically developed and conform to appropriate standards of
identity, strength, quality, purity of components.
7) Provide timely responses to internal and external inquiries
8) Resolving any queries with respective to Development, Validation and Verification data.
9) Reduction of down time with respect to various instruments.
10) Training to new entrant and existing staff with respect to Validation activities and GLP norms.
11) Designing, Documentation and Qualification / Verification of various calculation sheets by
using Excel and word.
12) Overall responsible for the smooth functioning of Formulation – Development, Stability
study, Validation study.
13) Ensure specific objectives and goals of the department are met.
Achievements in organization :
Joined the organization as a trainee research associate in Yr. 2006 and by showing the continuous
efforts towards the excellence, became Manager-I and became a key person of the
organization.
2
)
Company Name: Hiran Orgochem Limited Since June 2005 to December 2005
1) Performed analysis of In-process sample and routine QC sample analysis of API and as per
in-house specifications and as per official monographs.
Additional Information:
IT Knowledge: 1) Well verse with LIMS systems.
2) Well verse with modern communication methodology : Internet
3) Well verse with : Microsoft WORD, Excel, Power Point
4) Basic Knowledge of Networking in LAN environment
3. 1
Personal Details:
Date of Birth:
Age:
Marital Status:
Father:
Mother:
Wife:
Child:
21/06/1983
32 years
Married
Farmer
House-Wife
House wife
Senior KG
Sutarsandhiya Ruturaj K