Resume

VIJAY GARMODE

plot no. *** A, Silver Star city

Indore, MP

e-mail: adm4q8@r.postjobfree.com

M. No. 982-***-****(Home), 846-***-****(Official)

Career Objective:

To explore myself in the world of pharma. and touch the new horizons in the arena of quality assurance, quality control and Microbiology, to work in an innovative realm of healthy competition.

Academic Qualification:

M.Sc- (Biotech.) from Amravati University.

B.Sc- (Biology) from Amravati University.

Name Of company :

Years Designation

Chaitnya biological pvt.ltd. (Malkapur, Maharashtra)

1 year (Officer Q.C.)

Z.Y.G Pharma pvt. Ltd. (M.P)

From 19 sep.2005 to 22 Oct. 2010 (Section head, Micro.)

Cipla Ltd. Pithampur, (M.P)

From 25 Oct. 2010 to 31 Mar.2019 ( Assistant Manager Lab QA )

Cipla LTD.Pithampur ( M.P.)

From 01 April 2019 to till date. ( Assistant Manager QA )

Previous Experience:

A) Microbiology:-

Microbial limit test (MLT) (FG,PM,RM, Water ), Bioassays of raw materials & finished products, Environmental monitoring(SWAB,AIR SAMPLING,SETTLE PLATE), Preservative efficacy test. (PET), Growth promotion test. (GPT), Maintenance of microbial cultures

B) CHEMICAL :-

Stability study (sample pull out, sample charging, sample reconciliation activity & data logger activity), Reserve sample activity (FP & RM)

Coordination

Coordinated with manufacturing team, QC team, Engineering, Packing area,SQC, CQA and warehouse functions to ensure compliance to the quality system.

Current Job Responsibilities

Being an Assistant Manager, I execute the work assigned to me, I also take follow ups from respective stakeholders. I have also undertaken following tasks.

To ensure compliance cGLP /cGMP as laid down in the procedure.

Responsible for the planning, implemention, and coordination of DATA Integrity program.

Participated in the investigation related to data integrity and corrective action for reported improper practice.

To ensure training and awareness session on Data integrity at the time of on boarding and during annual refresher training or as and when required. Data integrity overview training will cover organizational mission, How and When to report data integrity issues, record keeping practices and data integrity procedure documentation.

Preparation /review and approval of QA related all types of documents.

Ensure all master and completed documents are reviewed for adequacy, completeness, and compliance with cGMP requirements.

Responsible for conducting internal audit and external audit as per pre define schedule and ensure compliance to the observations made during audit.

Ensuring and verifying qualification activity of equipments and instruments.

Monitor the investigation in case of excursion/breakdown of stability chambers/incubators.

Handling of Change control activity and ensures changes are implemented as per the procedure.

To ensure proper investigation of Deviation,CAPA, Root Cause and risk management.

To ensure proper investigation OOS, OOT, PE, TE, SST,SE.(investigation) & reprint activity.

To ensure proper review and release of batch at in process, finished product, API and excipients.

To ensure the preparation and review of APQR data .

Review of critical instruments calibration and preventive maintenance.

Review stability STF, Protocol, Blank TDS and ATR.

Review retention sample records and stability as per ICH guidelines.

To check Audit trail in SAP, LIMS, CIPDOX, Chromeleon and other instruments in QC.

Daily reconciliation of electronic data generated for the controlled software for hard copy vs. soft copy.

Periodic review of system Audit trail and 21 CFR activity.

To operate LIMS based on the roles and rights provided in the application.

To operate the SAP based on the roles and rights provided in the application.

To operate CIPDOX based on the roles and rights provided in the application.

Regular quality control Lab round as per cGLP.

Release, approval and issuance of BMR,BPR,Process order.

Approval and issuance activity of MBPR and MBMR.

Coordinating with training activity (LMS).

Issuance and retrieval of PMS.

To operate e-track (Warehouse activity ) based on the roles and rights provided in the application.

Screening and identification of Elemental impurity .

Screening and identication of Nitrosamine impurities from verious drug products and API, Excipients, Primary Packing Materials.

Validation:

Water, MLT, Bioassay, Autoclave

Instruments Handled :

Disintegration, Friability, Refractometer, U.V., I.R., Dissolution, KF.

Handling of Software :

LMS (Training ), QCMS, Chromeleón, SAP, TQC, Cipdox, LIMS, Trackwise, e-track (Warehouse)

Audits Faced.

W.H.O, M.H.R.A (U.K), T.G.A (Australia), M.C.C (South Africa), US FDA

Strength :

Hardworking, Self Motivated, Flexibility in work, Adaptability and Positive Attitude.

Weaknesses :

Sensitive and introvert.

Hobbies :

Listening music, reading and spending quality time with family and friends.

Personal Information:

Name

VIJAY E. GARMODE

Father s name

Mr. EKNATH GARMODE ( Rty. Tahsildar )

Wife

Vinanti Vijay Patil

Profession

Teaching ( Ryan Inter national School )

Nationality

Indian

Languages

English, Hindi & Marathi

Marital Status

Married

Present Location

Indore

Present CTC

9.5 lacs/annum

Expected salary

11.0 lacs /Annum

Notice Period

02 Month

References

Mr. Chirayu Mehta { Head CQA, Teva Pharmaceutical, Bombay}.

(Mobile No. 842-***-****)

Mr. Devendra Devangan { Tech Transfer Head, Cipla LTD, Pithampur}

(Mobile No.837-***-****)

Mr. Darpan Chopra { DGM Quality, Mylan Laboratory, Pithampur}

{Mobile No. 887******* }

Declaration: I hereby declare that all the above information is true and correct to best of my knowledge.

Date:- 01.06.2021 Place: Indore

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