SAMADHAN PRABHAKAR PATIL

Address: At post Gondgaon, Tal.Bhadgaon; Dist.Jalgaon

Maharashtra, India.Pincode-424103

Contact No. +243********* (Available on Whats App)

E-Mail – ac7bp8@r.postjobfree.com

Personal

Snapshot

2 Year 4 Month Experience in Pharmaceutical Quality assurance as a Sr. QA Officer with regulatory compliance Organization and following audits are faced.

●USFDA, MHRA, Ministry of Health CONGO, Customer Audits, Corporate Audits and Internal Audits,EU GMP, UGANDA,etc.

Objective

● To join a company in which I can contribute my knowledge and skills, a company which provide me a platform to work with and learn from talented people and accept my little contribution to the growth of the company.

Professional experience

(6 year 4 month)

Presently working in ARAUPHAR PRODUCTION SARL, KINSHASA; DEMOCRATIC REPUBCLIC OF CONGO, AFRICA from JAN 2018 to Till Date as Sr. QUALITY ASSURANCE OFFICER.

I have worked as Officer Validation QA in Sterile Manufacturing Company CIPLA PVT. LTD. GOA from JULY 2016 to DECEMBER 2017.

Professional Qualification

Bachelor of pharmacy from R.C.PATEL INSTITUTE OF PHARMACEUTICAL EDUCATION & RESEARCH SHIRPUR, DHULE; NORTH MAHARASHTRA UNIVERSITY, INDIA. With 1st Class.

Higher secondary from Rastriya Vidyalaya College, Chalisgaon. (Nasik Board), 2012 with 1st Class.

Secondary school from Madhyamik vidyalaya Gondgaon; Tal.Bhadgaon, Dist.Jalgaon, Maharashtra; (Nasik Board) 2010 with Distinction 81.45%.

Career Conspectus

2 year 4 month experience in Pharmaceutical Quality Assurance.

Expertise in QMS (Quality Management System) Change control, Deviation, Investigation, CAPA, Risk Assessment, Impact Assessment, Market Complaints etc.)

Implementing technical documentation (validation protocols report, SOPs, specification and STP, and audit system)

Strong skills in change control and technical documentation.

Vendor Audit and vendor approval.

Handling of Out of Specification, Out of trend, laboratory Investigation etc.

Excellence in identifying nonconformities, conducting investigations and improving practices.

Conducting Self Inspection as per Inspection schedule

Implement the Aseptic process simulation activity as per regulatory requirement.

Coordination between various departments like Production, Quality Control, warehouse, engineering or Quality assurance.

Qualification and validation

Process Validation

Cleaning Validation

Autoclave, Vial Washing machine (BOSCH) Vial Sealing Machine

HVAC System, Water System (TSA)

In Process Quality Cheeks

Reviewed cGMP documentation of shop floor activities, line clearances

To ensure that the Standard Operating Procedures are followed in day-to-day activity.

To grant line clearance at different stages of manufacturing and packing of Injection & LVP.

Verification of raw material / packaging materials during dispensing stage.

To ensure on line completion of batch manufacturing and packing records.

To ensure the stage wise yields are within the specifications mentioned in batch manufacturing and batch packing records.

Issuance of documents likes BMR, BPR, and Validation Document.

Review of BMR, BPR, and Validation Document.

Responsible for Document control

To collect the in process and finished product samples.

Data collection and prepare Annual Product Review

To ensure that appropriate calibration and preventive maintenance of manufacturing equipment’s.

Familiar with media fill

To prepare hold time study protocol & report

Execution, sampling and compilation of validation report.

Prepared shift scheduled for IPQA section.

Computer Skills

Microsoft Office Operating Systems: Windows 98, 2000, XP, 2007.

Knowledge of MS-office, and familiar with the internet.

Industrial Training & Project Work

Project Topic: Indolene-2 ones in clinical trial as an anticancer agent.

Personal Profile

Name : Samadhan Prabhakar Patil

D.O.B : 10-10-1993

Father’s Name : Mr. Prabhakar Natthu Patil

Sex Status : Male

Permanent add. : At post Gondgaon, Tal.Bhadgaon ;Dist.Jalgaon

Marital Status : Unmarried

Language Known : English and Hindi

Nationality : Indian

Strength

Believe in team work, hard work and better perform in time Restrained environment.

Self management, excellent oral and written communication skill.

Notice Period

60 days

Declaration

I hereby declare that all the information provided by me is correct

To the best of my Knowledge and belief.

Date :

Place: (Samadhan Prabhakar Patil)

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