RESUME

Name : Gaikwad Sudarshan Arun

Branch : B.Pharmacy

Mobile Number : 885*******

Email Id. : adq146@r.postjobfree.com

PERSONAL DETAIS

Objective :-

To seek a place where I can use my knowledge, upgrade my skills & contribute to the organization with my full potential.

Education Qualification:-

Exam

University/Board

School/College

Year of Passing

B.pharmacy

University of pune

Matoshri college of pharmacy,Nashik

2018

H.S.C

State board of Maharashtra

K.M.Agrawal college,Kalyan

2012

S.S.C

State board of Maharashtra

St.Thomas English High School

2010

Projects:-

INDUSTRIAL VISIT PROJECT – ‘MICROLAB PVT.LTD’

INTERNSHIP TRAINING - “HOLDEN LABS PVT.LTD,SINNAR”

Title – A Review On “ ALZHEIMER DISEASE ’’

Professional Interest:-

Quality Assurance.

Quality Assurance Analyst.

“Research & development” and “Formulation & development”.

Experience:-

Crescent pharma Pvt.Ltd as Quality Assurance chemist from September 2018 to July 2019.

Vital health care Pvt.Ltd as Quality Assurance Officer from August 2019 to October 2020.

Kilitch Drugs (India).Ltd as Quality Assurance Officer from November 2020 till date.

Total Exp:- 3.3 years.

Audit faced : TMDA, WHO, PIC’s, Yemen, Regulatory audits.

Job description:-

1)Kilitch Drugs (India).Ltd:- (Liquid Inj,Powder Inj and ophthalmic solution).

To carry out Validation Activities by scheduling, coordinating and executing with Concerned Departments.

Types of validation carried out DHS Validation, Autoclave Validation, Equipment Validation, HVAC Validation.

To carry Out Self-Inspection Activity by coordinating with Auditors and Auditee. As well as data Compilation.

Review BMR and BPR as well as filing it with Proper compilation of data.

Reviewing Media fill Batch Records.

Stability chamber upkeep and Sample Loading and Sample scheduling on OASIS LIMS 4.0.

Providing Stability Samples to the Q.C for Analysis As per the stability schedule.

Taking Follow up and coordinating with Q.C to obtain the stability Analysis Data.

Preparing Stability Summary Sheet and with Proper compilation of stability Data.

Checking of Finished product Certificate of Analysis and coordinating with marketing and logistic Department.

Handling Change control,Deviation, CAPA,NCR,Market complaint register as well as compilation of reports.

Specification preparation for Finish Product and Raw material

Preparation of Analytical Method Validation Protocol with Reports and Compilation of data.

Supervising IPQA Members, If any Discrepancy observed or reported by IPQA Member, carry out the sensitivity of the issue if major issue observed as well as minor then reporting the details to Q.A Executive with complete data of the issue.

Carry out Third party visit to there manufacturing plant and carry out Inspection by coordinating with the In house Seniors as well as Third party Official members.( Maneesh pharma.Pvt.Ltd and Kamala Lifescience.Ltd)

2)Vital Healthcare Pvt.Ltd :- (Liquid Inj,Powder Inj and ophthalmic solution,Sterile Ointment formulation).

Responsible and monitoring all IPQA related activity dispensing to dispatch.

Doing in-process activity during Manufacturing, Washing and filling of ampoule, vial as well as labeling and packing.

Co-ordination for action required against incidences happened in Production and related impact assessment.

Monitoring the Dispensing activities.

Monitoring and review of the viable particle count and non-viable Particle data in respective areas.

To daily check the documents like records and log books.

Review Batch Manufacturing Records and Analytical document.

Involved in “PROCESS VALIDATION” activities like to supervise and sampling.

Review and further proceedings to BMR and BPR and its online checking and compliance.

Process validation sampling in all stages of Parentral preparation.

Sampling of in process sample and sending samples to QC lab.

Line clearance and supervision during of Parentral preparation.

Line clearance and supervision of dry powder infusion.

Issuance of BMR/BPR.

Preparation of SOP and BMR .

Supervision of Environment monitoring and Area cleaning.

APQR preparation and data compilation.

To carry out Validation Activities by scheduling, coordinating and executing with Concerned Departments.

Types of validation carried out HVAC Validation.

3)Crescent Pharma Pvt.Ltd:- (Liquid Inj,Powder Inj and ophthalmic solution, Ointment formulation).

Responsible and monitoring all IPQA related activity dispensing to dispatch.

Doing in-process activity during Manufacturing, Washing and filling of ampoule, vial as well as labeling and packing.

Monitoring the Dispensing activities.

Monitoring and review of the viable particle count and non-viable Particle data in respective areas.

To daily check the documents like records and log books.

Review Batch Manufacturing Records and Analytical document.

Review Batch Manufacturing Records and Analytical document.

Sampling of in process sample and sending samples to QC lab.

Line clearance and supervision of dry powder infusion.

Supervision of Environment monitoring and Area cleaning.

Line clearance and supervision of Packing process.

Final Inspection of packed batches Before Release.

Extracurricular Activity :-

Worked in GSK Biologicals Asia Pvt.Ltd,Nashik on contract basis in packing department.

Internship at Holden labs Pvt.Ltd,sinnar,Nashik on tablet formulation.

Poster Presentation on ‘ New Drug Discovery' at state level organised by university of pune.

RAP ANALYTICAL NASHIK- SEMINAR.

Skills :-

Strong knowledge of Ms-word, Ms-Excel.

Fluent English.

Personal traits :-

Innovative and a good in team work as well as target oriented lead.

Positive attitude to learn new technologies

Excellent organization planning and problem solving abilities.

Honest and determined in nature and can work under extreme condition.

Personal details:-

Name - Gaikwad sudarshan arun

Date of Birth - 24/11/1994

Permanent Address - 302,B-wing,kashinath apartment, opp uma fertility centre,

Chickenghar highway,kalyan(west). pin:-421301

Hobbies - Reading books, Photography, gaming, rapping, Learning.

Sports - Cricket, volleyball, badminton.

Strength:-

Decision making power & Positive approach towards Problems.

Complete work within time.

Adaptable according to Environment.

Positive attitude towards work.

Language known:-

English

Hindi

Marathi

Declaration:-

I hereby declare that the information furnished above is true to the best of my knowledge and belief.

GAIKWAD SUDARSHAN ARUN

Contact this candidate