DIPIKA L MARATHE
Email : marathe.dipika91 AT gmail.com
M. Pharm(Quality Assurance)
OBJECTIVE :
To work in a healthy, innovative and challenging environment extracting the best out of me, which is conducive to learn and grow at professional as well as personal level thereby directing my future endeavors as an asset to the organization.
CAREER OVERVIEW :-
Awareness of QBD (Quality by design) : QTTP, CQA, CPP, Risk Management, Change Control, CAPA, Design space & Control strategy.
Knowledge of various guidelines by FDA as SUPAC (IR) & (MR),Method Validation Process Validation, Sampling during Validation batches, ICH – Stability Guidelines, Product development Report as perQbD inCTD format etc.
WORK EXPERIENCE :
G. AMPHRAY LABORATORIES :( As a QA/QC officer)
Tenure : From March 2015 to Till Date
KEY ACCOUNTABILITIES :
QA Department :
** Facing Audit as Co-Core Team Members.
** Ensure all regulatory requirement of health authorities are met and supply continuity for the products are maintained.
** Ensure informing stakeholder and request of documents information sufficiently ahead of time and follow up for timely delivery.
** Detailed review of document to ensure it meets regulatory requirement.
** Plan and Prioritise variation submissions based on nature criticality of change using information available. Example-compliance risk
** Ensure timely completion of assigned deviation and CAPA.
** To coordinate with the testing laboratories and manufactures for timely analysis and provide support during technical troubleshooting.
** To ensure that the relevant database is update with every batch released.
** To report any out of specification or out of trend result and assist the deviation during investigation.
** To improve the overall cycle time on batch release.
** To review batch documents and confirm that the batch meets the relevant regulatory standard.
** To assess the performance of every manufacture and prepare a risk assessment report determining the level of detailed information required during batch release.
** To ensure that batch release and other associated SOP are thoroughly followed and suggest improvement.
** Preparation of monthly report.
** To ensure that adequate and complete records relationg to GDP are maintained.
** To ensure Product Quality review procedure thoroughly followed.
** Preparation of Documentation as per ISO 9001 :2008, ISO 9001:2015, OHSAS 18001:2007, ISO 22000:2005 & FAMIQS.
** Preparation of Documentation as per Local cGMP & FDA requirements.
** Party Fill the Supplier and Vendor Questionnaire
** Handling Customer Complaints. Investigation of Root Causes.
** Preparation of Deviation, Change Control,OOS (Out of Specification).Corrective & Preventive Action Plan (CAPA).
** Maintaining, reviewing & upgrading various Quality Assurance record like Validation, Calibration.
** Preparation of BMR/BPR Master Copy , Control Copy.
** Preparation of SOP, Specification, Method of Analysis.
** Party Specification Check with Our Specification.
** Preparation of Certificate of Analysis as per BP, USP , IP , EP & Party Specification.
** Issue Blank BMR/BPR to production and Check Completed BMR Reviewed & Retrievals & Document Store.
** Prepared Minutes of Meetings.
** Review ATR, TDS, COA, BMR, BPR, and sign.
** Ensure Analysis data and maintain the logs.
** Prepared monthly quality presentation and compilation of same.
** Provide Administrative Support to Team.
** Collect weekly Updates and do trending in excel or tools.
** Preparation of Monthly Stock Statement of Chemical, labels & Measurement of objective of Finish Product , PM ,RM & Instrument Yearly calibration Plan.
QC Department :
** Analysis of Raw Materials , Packing Materials, In process sample & Finish product .
** DM Water testing and reporting.
** Preparation of Reagent, Indicator, Volumetric solution & standardization .
** Preparation of finish product COA as per requirements.
** Sampling of raw materials & finish product as per requirements.
** Daily & Monthly calibration of instrument , Balance, pH Mater, KF- Water Factor.
MAHAVIR HOSPITAL : ( As a Register Pharmacist )
Address : Mahan MedicalUlhasnagar (Maharashtra , India)
Post Held : Pharmacist
Tenure : 1 Years in (2014-2015)
PARTICIPANTES AND CERTIFICATE :
** Participate in National Level ePoster Competition on COVID-19 Pandemic.
** Participate in Online State level innovative Article writing Competition on Coronavirus Crisis.
RESEARCH PAPER PUBLICATION :
Development and Validation of Analytical Method for the determination of Bioactive molecule in bulk and Pharmaceutical Dosage form.
Journal Name :JETIR (Journal of Emerging Technologies and Innovative Research)
TRANING :
One Month Industrial Training at MAMBRO Pharmaceutical, Dombivali.
EDUCATIONAL CREDENTIALS :
** M.
Pharm (Quality Assurance) 2020 Siddhant College of Pharmacy Pune (Pune University) Till 3rd Sem 8.14 CGPA
** B. Pharm 2013 Konkan Gynpeeth College of Pharmacy (Mumbai University) 59%
** HSC 2009 New English Jr. College (Mumbai University) 62%
** SSC 2007 Takshashila Vidhyalaya (Mumbai University) 78 %
ACHIEVEMENT :
Qualified GPAT 2018 with 96.47 Percentile
PROJECT M. PHARM :
M.Pharm Project : Development and Validation of Analytical Method for the determination of Bioactive molecule in bulk and Pharmaceutical Dosage form.
SCIENTIFIC AND PROFESSIONAL AFFILIATIONS :
Registered Pharmacistof Maharashtra State Pharmacy Council.
COMPUTER SKILLS :
Microsoft Office (Microsoft Word, Microsoft Excel, Power Point, Internet) & other basics of Computer
PERSONAL DETAILS :
Name : Dipika L Marathe
Date of Birth : 7th Nov 1991
Marital Status : Married
Nationality : Indian
Languages Known : English, Hindi, Marathi
SELF- ASSESSMENT :
Self-motivated and loyal individual with a strong passion for success in every field of life. Being a responsible person with a good analyzing mind helps me to combat every difficulty and face challenging assignments successfully and with ease. I hereby solemnly, do affirm that the particulars furnished above are true to the best of my knowledge.
Note :
Mobile phones are not allowed in the premises of the current company. If possible please contact via Email.
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