NISHA KISAN ARUTE

nishiarute@gmail.com
Mob No. 09637577044, 09769897085

Objective:
Intend to build with leading corporate of hi-tech environment with committed & dedicated people, which will help me
explore myself fully and realize my potential. Willing to work as a key player in challenge and creative environment.

Experience:
Currently working with FLAMINGO PHARMACEUTICALS LTD. Taloja From July-2017 to till date as a
Sr. Executive – Quality Assurance.
Job Profile:-
 Handling of QMS activities like conducting investigations, change controls, deviations, CAPA, incidents,
market complaints, OOS.
 Responsible for Login, evaluation, investigation and trending of change control, OOS, Market complaints,
Deviation, incidents. Reviewing status and follow-up for the closure and ensure corrective and preventive
actions for the same.
 Responsible for self inspection/internal audit and ensure CAPA and trending of the same.
 To plan MQRM and Preparation of management quality review meeting report (MQRM) and PPT.
 To Review and approve of analytical method validation/verification protocol, method transfer documents,
qualification, calibration, and excel sheet validation documents.
 Responsible for preparation of VMP and site master file.
 Responsible for preparation of training schedule and to conduct training to the employees as applicable.
 Review of raw material, in-process, semi finish, finish, stability reports, Standard analytical procedures,
Specifications and other quality control procedures.
 Preparation and review of standard operating procedures and ensures implementation.
 Responsible for preparation and review of stability protocol and APQR.
 Responsible for preparation of gap analysis for specifications and analytical methods.
 Responsible for reviewing of batch records and releasing the batches in SAP with COA and to maintain
documents related to batch release.
 Review of vendor documents like Specification, Method of analysis along with COA etc. and to maintain
documents related to vendor audit.
 To inform about changes received from manufacturer related with changes in specification/ CEP/
manufacturing process etc.
 Responsible for compilation of responses to queries from customers/regulatory authorities.
 Review of Analytical method validation /manufacturing /quality control record for submission of dossier.
 Review of analytical, R & D documents of drug product for adequacy and regulatory compliance.
 Coordinate with plant, R&D, CQA and ADL dept. for technical documents as per regulatory requirement.
Worked with “CENTAUR PHARMACEUTICAL PVT. LTD.” Vakola, Santacruz, Mumbai in R & D (Q A)
and in Hinjewadi, Pune, as a QC Officer from Sep-2014 to Jun-2017.
Job Profile:-
 Responsible for preparation, review and revision of Raw material, In-process and finished product
specifications against regulatory queries / Periodic review, preparation of protocols & reports for Method
validation, Review of test data sheets and raw data(Finish/RM/Stability), Ensure preparation of specifications,
MOA complying with regulatory guidelines and current pharmacopoeias. Preparation of calibration schedule
and protocol for calibration.
 Responsible for preparation, review and revision of SOP as per requirement at both the site (Head office/
Ambernath/Pune plant) and implementation of the SOP’s by imparting training to the employees as
applicable.
 Co-ordination and collection of dossier data and samples from plant and ensuring all documents required for
DMF submission in collaboration with other plants and departments, attendance of project meeting.
  Review of analytical, R & D documents of drug substance for adequacy and regulatory compliance.
 Responsible for application of test and manufacturing license.
 Looking to QA activities (Preparation, review and issuance, archival , maintenance of LNB’s/ documents).
 Responsible for logging of change control. Reviewing the monthly status of change controls and follow-up for
closure of the same.
 Actively participate in the activity related to various FDA audits at Ambernath/Pune plant and crosscheck the
auditable documents compiled by R & D department.
 Responsible for Creation and change of master inspection plan in Systems applications & products in data
processing (SAP) for Raw material, In-process and finished product.
 Responsible for initiation of deviation/ incidence if required, change control for revision of specifications,
initiation of ratification, incidence.
 Worked as Lab QA Responsible for talking round in QC lab, observations to be noted and reported.

Worked with “Ajanta Pharma Ltd. Paithan” in Quality Control From Oct -2013 to Sep- 2014 as a Quality
control officer:
Job Profile:-
 Analysis of Formulation Products including Tablets, Capsules & Reporting through LIMS.
 Preparation and review of STP’s, Specifications.
 Review of Analytical data.
 Handling of Laboratory Information management System Software (LIMS) and reporting of analytical data in
LIMS.
 Maintaining the log of working standards/Reference standards through LIMS

Worked with Wockhardt Ltd. Aurangabad” in Quality Control From Mar-2012 to Oct- 2013 as a Quality
control Senior Officer:
Job Profile:-
 Analysis & Reporting of Formulation Products including Tablets, Capsules & Injections, Ophthalmic
Solutions etc.
 Maintaining the log of working standards/Reference standards.
 Preparation of SOP’s, STP’s, Specifications, Record of Analysis, Certificate of Analysis etc.
 Maintaining the log of standard instruments.

Worked with “MEPL, Pune” in Quality Control From Jun-2010 to Jan-2012 as a chemist.
Job Profile:-
 Drinking water / Waste water Analysis.

Personal Skills and Competencies:

 Quick learner and can easily adapt to new and changing situations.
 Quickly establish and maintain effective rapport with individuals of diverse backgrounds
 Self motivated achiever with an established reputation for reliability, hard work, commitment, team work and
flexibility.

Academic Credentials:
 M.Sc.: (Organic Chemistry) From Pune University. Year - 2010 with Higher second class
 PGDBA: From Symbiosis Institute of Management. Year - 2016 with A+ grade.
 B.Sc.: (Chemistry) from Pune University. Year - 2006 with First class.
 H.S.C.: From Pune. Year - 2003 with Higher second class
 S.S.C.: From Maharashtra board Pune. Year - 2001 with First class with distinction.

Computer Literacy:
 MS-Office with basic knowledge of Computer.
  MS-CIT
 Knowledge of Internet.

Instruments Handled:
 Handling of highly equipped (computerized) instruments HPLC with auto sampler of Agilent 1100, 1200,
1260, 1290 series, Software EZ Chrome, Open Lab Solutions.
 UV Spectrophotometer (Shimadzu). UV-Visible spectrophotometer (Shimadzu UV 1700).
 Dissolution Apparatus (Electro lab, Lab India).
 FTIR Spectrophotometer.
 Disintegration tester.
 Friability tester.
 Autotitrator & Karl Fischer (Metrohm).
Personal Details:
Date of Birth : 10TH May 1986
Present Address: Shree Ganesh Co. SocietyA-3/504, Sec-28, Nerul (West), Near Nerul Gymkhana, Navi
Mumbai, State - Maharashtra, Pin:- 400 706.
Languages Known : English, Hindi, Marathi.
Hobbies:
 Interacting with People
 Listening music, watching movies
 Playing indoor game.

Current Salary: 6.2LPA.

Expected Salary: 8LPA (Negotiable)
Reporting To: Head Quality(AGM)
Total Experience: 10+ years
Notice Period: 1 month
Current Location: Taloja, Navi Mumbai
Products Handeled: Tramadol, Piroxicam, Omeprazole Capsules, metformin, Gabapentin,
Bisacodyl, Paracetamol,Ibuprofen tablets etc.

Avowal:
I hereby declare that the information furnished above is true to the best of my knowledge.
Thanking You.

Place: Mumbai.

Date: Nisha Kisan Arute