Seeking to obtain a challenging Quality assurance or Regulatory Affairs position providing

professional career growth in the pharmaceutical/biotech industry. OBJECTIVES

Intend to build a carrier with leading organization with dedicated people which will help me to explore myself fully and realize my potential.

To make positive contribution towards promoting team spirit in meeting the objective of organization and own professional growth.

SUMMARY

M. Pharm (QA) from Parul Institute of Pharmacy, Vadodara affiliated to Gujarat Technological University.

B. Pharm from Anand Pharmacy College, Sardar Patel University, Gujarat EDUCATIONALQUALIFICATION

Exam passed Year Institute/Board Percentag

e/

Grade

M. Pharm. (Quality

Assurance)

2013

Parul Institute of

Pharmacy, Vadodara,

GTU, Gujarat

7.52 CPI

GPAT May’2011 AICTE, New Delhi 20.67 percentile (All India Rank-3110)

B. Pharm.

May’2011

Anand Pharmacy

college, Anand,

SP University,

Gujarat

67%

Diploma in Pharmacy 2008 S. K. Patel college,

Kherva,

Gujarat

73%

H.S.C. (12thScience) March’20

06

GSEB 60.60 %

S.S.C. (10th std) March’20

04

GSEB 72.86%

Distinctio

n

Priyakumari Mishra

Contact No.: +91-902*******

E-mail: ad0t3u@r.postjobfree.com

Address: C-201 Sai raj Regency, Pimple Saudagar Pune-411027 DISSERTATION UNDERTAKEN

Process Validation of Pye-M (Pioglitazone & Metformin) bilayered extended release tablet.

WORK EXPERIENCE

1. Company: Osaka Pharmaceuticals Pvt. Ltd., Vadodara Designation: Regulatory officer

Year: From Apr 2013 to May 2014

2. Company: VHB Lifescience Pvt. Ltd., Mumbai

Designation: Junior Officer-Regulatory Affairs

Year: From Sep 2014 to March 2016

3. Company: Aura Lifecare Pvt.Ltd., Mumbai

Designation: Regulatory Affairs officer.

Year: From May 2021 –April 2023

COMPETENCIES

Preparation & checking of dossiers for ASEAN countries (Cambodia, Laos, Myanmar & Vietnam) & African countries (Tanzania, Nigeria, Ethiopia, Liberia, Kenya, Burundi, Sierra Leone, Ghana & Uganda).

Checking of Artwork, coordinate with factory for samples, working standards & Plant documents.

Coordinate with the client on technical requirements for Plant inspection documents, dossier submission, fees submission.

Maintaining status and record of dossiers, samples & registration status.

Knowledge of GMP, USFDA, ICH, CTD & ACTD guideline.

Understanding of IPQA checks during dispensing, manufacturing, filling, packing and dispatch of drug products.

Preparation of annual product review of various products manufactured in the facility.

Part of the review process of all critical parameters from the raw material arrival till the dispatch of finished product.

Review and update of existing Standard operating Procedures (SOP).

Knowledge about Process Validations, Analytical method Validation & Stability Study.

Preparation and review of BMR & BPR.

Preparation of COA (Certificate of analysis), Specification & MOA (Method of analysis).

Knowledge of Legal documents such as Certificate of Pharmaceutical Products, Manufacturing License.

IT SKILL SET

Knowledge of Microsoft Word, Excel, Power point and overall Office knowledge

OS – Windows XP, 7.

Packages – UV Probe, Spinchrome, Pharmasuite.

EXTRACURRICULARACTIVITIES

Participated in Novel Drug Delivery System – a state level Seminar – March, 2008

Won first prize in Fashion Show in Pharma GujFest 2009, held at Ganpat University, Kherva, Gujarat

Participated in Badminton (Doubles) in state level competition at Anand Pharmacy College, 2009

Won multiple prizes in Debate Competition, Rangoli Competition at College level

Participated in workshop on IMPORTANCE OF QUALITY ASSURANCE IN DIFFERENT PHARMACEUTICAL AREAS jointly organized by BARODA college of Pharmacy & Parul Institute of Pharmacy, from 9th to 11th March, 2012.

Participated in GUJCOST Sponsored workshop on PATENT DRAFTING jointly organized by BARODA college of Pharmacy & Parul Institute of Pharmacy, from 14th to 15th September, 2012.

Participated in national conference on QUALITY BY DESIGN: AN ESSENTIAL REQUIREMENT IN PHARMACEUTICAL INDUSTRY organized by GTU, held on 16th & 17th March, 2013 at Parul institute of pharmacy. ASSETS

Confidence, positive attitude and self-belief.

Hard and smart working.

Adapting myself to any term or environment.

PERSONALDETAILS

Date of Birth: 18th June, 1988

Place of Birth: Arrah, Bihar

Gender: Female

Marital Status: Married

Languages Known: English, Hindi, Bhojpuri and Gujarati Date: Yours Faithfully,

Place: PRIYAKUMARI MISHRA

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