Training Machine

CURRICULAM VITTAE

RAKESH R. YADAV

CONTACT ADDRESS

Shri Ramlakhan Yadav

Village- Belwa Bagia, Babuganj,

Post- Phulpur,

Dist- Allahabad- 212404 (U.P),

Country: INDIA

Mobile No: 0091-935-***-**** / 0091-980-***-****

Mobile No: 0091-962-***-****

Mail Id: ***********@*****.***

B-Pharmacy

Expertise In :- Validation Dept

OBJECTIVE:

I am looking forward for a position in Validation Dept. I expect a career

which is different yet unique, my intelligence is continuously nourished by

challenges and constant quest for knowledge is honed on the newest of the

technologies.

PROFESSIONAL SYNOPSIS

* Near about 9 years of experience in Validation / Production Department

& Seeking a change in Validation Dept / CQA Dept .

* Approved chemist in Semi-Solid.

* Handling of Change Control and Deviation.

* Preparation of Annual product review

* Preparation of SOP

* Preparation of validation protocol

* Arrange various Training Programme and Its Module

* Handling of market complaints and their corrective action and

Preventive action.

* Self-Inspection and Auditing for cGMP norms.

* cGMP Training to the Operator and Coworker.

* BSR Transfer and Final Inspection of Finished goods.

* IQ\OQ\PQ of production equipments

* Process Validation of Tablets and Capsules

* Exposure in Tablet Sections (OSD), Dry syrup, Ointment & Oral liquid.

* Team Work & extremely Goal focused and Hard Working.

* Keen Understanding on the implementation & Documentation.

* Effective in reducing damaging losses by implementing highly effective

procedure and proper handling of man, material and machine.

* Multi task taking abilities, strong analytical decision making and

organizational.

* Achievement oriented with an ability to manage change with ease.

* Ability to manage stress, time and change effectively.

Projects: - Handling, documentation, Qualification, start up &

Validation of following Projects:

* Tablet, Dry syrup & Liquid Oral Production Facility

Over all Documentation of all the above sections as per Validation

Master Plan (SOP's, URS, FAT, IQ, OQ, PQ etc. preparation and

execution).

* Preparation of BMR's / Validation Protocol.

* Technical discussions with different parties, budgeting and project

deadline preparation.

* Preparation & Execution of Validation related Protocols.

* Trained the manpower to achieve Organizational goal and GMP compliance.

* Department Coordinator for QA related activities.

AUDIT FACED

MHRA (UKMCA), MCC, US FDA, ANVISA Brazil, WHO, INVIMA Columbia,

Romania etc.

MACHINES HANDLED

* Vibro sifter 30"

* Planetary mixer

* Tablet Compression Machine - CADMACH

* Sifter cum multimill,Multimill

* Conta blender,Octa blender,Drum blender,cage blender.

* Roll compactor, Oscillating granulator, Rapid mixer granulator

(150Ltr,250 Ltr,400 Ltr .600 Ltr 1000 Ltr )

* Fluidized bed dryer (60,120,150,250 Kg)

* Tray dryer (24,48,96 tray)

* Wimco filling & sealing machine of ointments

* Adam fabriwerk mfg machine of ointments

* Gansons filling machine of ointments

* J.P.Mehta Dry syrup filling machine

* J.P.Mehta ROPP capping machine

* J.P.Mehta Screw capping machine

* J.P.Mehta measuring cup placement machine

* Gansons sticker labeling machine

* LIQUID oral line from SPR sales and PHARMALAB (PLC based).

* Visco 16/8 Monoblock filling & sealing machine of Liquid oral.

* Visco 8/8 Monoblock Filling &Sealing Machine of liquid oral.

* Bectochem Manufacturing machine (PLC based) of oral liquid.

* Pharmalab manufacturing machine (PLC based) of oral liquid.

Educational QUALIFICATION

Professional Qualification:

* B.Pharma at Institute of Pravara Rural College of Pharmacy,

Pravaranagar under UNIVERSITY OF PUNE passed in 2004.

Academic Qualification:

* S.S.C. from Indian Rayon English Medium School (Birla Group), Gujarat

Board in 1998.

* H.S.C from Indian Rayon English Medium School (Birla Group), Gujarat

Board in 2000.

Computer Literacy: SAP, LMS, EPMS, TRACK WISE, DCM,MS Office, etc.

CAREER HIGHLIGHTS

Professional Experience:

* Currently working in Ranbaxy Laboratories Ltd (Daiichi Sankyo Group),

Baddi as a Validation & Training Head in Validation & Training Dept

April 2011 to till date (WHO Approved Plant).

* Worked in Dr Reddy's Laboratories Ltd, Hyderabad as Jr.Manager from

July 2007 to April 2011 in Validation Dept (Following Approval having

to this plant i.e. WHO / MHRA / USFDA / ANVISA).

* Worked in Indchemie Health Spl. Pvt .Ltd, Unit-III, Baddi (sister

concern of Alkem Group) as Production chemist from August 2005 to

June 2007 in Oral Liquid & OSD (Manufacturing & Packing) (WHO

Approved Plant).

* Worked in Radiant Parenterals Ltd, Baroda as a Q.A.Chemist from April

2004 to August 2005 in OSD, Semi Solid, Oral Liquid in (Manufacturing

& Packing).

ACHIEVEMENTS:

* Handled prime responsibilities in Manufacturing & Packaging of Tablet,

Semi-Solids, Dry syrup & oral liquid.

* Documentation in Tablet, Dry syrup, Semi-Solids & Liquid oral.

* To keep the Department updates as per latest cGMP

guidelines.

* Monthly production planning.

* Technology Transfer - Scale up of new formulation and its Process

Optimization and Validation.

* Batch Size Improvements - By utilization of facility/Plant Capacity

evaluation.

* Productivity Improvement - By Optimum utilization of available

Resources - Man, Machine & Materials with Process Monitoring.

* Yield Improvement - By reconciliation of Batch at each stage.

* Cost Improvements - By Cost Reduction Studies and regulating Materiel

Consumption through Batch Size Improvement, Yield improvement and

Productivity improvement.

* Downtime Reduction - Reduces the Downtime of Equipment and Processes.

Current JOB RESPONSIBILITIES:

* Equipment Qualification

* Training for new candidate as well as all the sop related training is

imparted through Learning Management System (LMS).

* Co-ordination with various departments such as store

(R.M./P.M./B.S.R.); Planning;

Regulatory Affairs (R.A); Q.C & Q.A; Maintenance; R & D and

Purchase.

* Preparation, Implementation and Updating of various documents like SOP'S

required as per the WHO, cGMP, GDP and new Schedule M Guidelines.

* Zero-defect maintenance of documents like Qualification Protocol.; and

various calibration records; including records of environmental

conditions - Temperature and Humidity records & Machine

logbook/Cleaning records.

* Monitoring of compliance with Standard Operating Procedures (SOP'S) and

other cGMP

Requirements.

* Support to validation team for carry out validation activities as per

validation master plan.

* Training - Job and Safety Training to workmen and make them understand

about importance of cGMP.

* Compliance to the regular self-inspection audits and prepare for

external audits.

PERSONAL PROFILE

Date of birth : 24th Dec 1979.

Father's Name : Shri Ramlakhan Yadav

Nationality : Indian

Gender : Male

Marital Status : Married

Language Proficiency : English, Hindi and Marathi.

Passport No. : A8618731

Hobbies : Travelling.

DECLARATION

I hereby declare that all the informations furnished above are true &

belief to best of my knowledge.

Date: (RAKESH R.YADAV)

[pic]

Contact this candidate