Ravi Kant Thakur

V.P.O-Slapper (Patta) Tehsil Sundarnagar

Distt- Mandi, Himachal Pradesh

Professional Profile         

· B. Pharma from Himachal Pradesh University (H.P.) with approx. 9 years 02 months of experience in reputed cGMP regulated, export-oriented Pharmaceutical Industries in QA (Validation & Project) functions.

·  Proven ability to interpret, establish and implement the Quality system as per the international regulatory guidelines.

· Hands on experience and expertise in routine validations, qualifications of facility, equipment, and utilities.

Exposure of Audits

·         USFDA

·         MHRA

·         WHO

·         UKRAINE

·         JAPAN

·         TAIWAN

·         INVIMA

·         ANVISA

·         MEXICO

Areas of Expertise

• Validation

Establishing Validation approach through Different and Specific Guidelines as like ISPE, GAMP, Validation Master Plan and Implementation of different validation and qualification activities like Water validation, HVAC validation, Area Qualification, Facility Qualification, Qualification of equipments and involved in Cleaning and Process Validation.

• New Project

·  Worked for Fresenius Kabi Oncology Ltd. and participated in lay out review, change controls, risk assessment, approving Conceptual Design Study, Project Validation plan, URS, DQ, IQ, OQ and PQ for different equipment’s (Autoclave, Tunnel and Washer, Filling Machine, DHS, Compounding and Holding Vessels, Lyophilizer, Isolator and CRAB,s & LAF etc.) HVAC, Water system and other utilities.

·   Worked for cGMP Pharma ‘n’ Plans Pvt. Ltd. and handled project of newly established facility of Immacule Lifesciences Pvt. Ltd., during the project phase of sterile injectables facility which includes the Validation and Qualification of following:

HVAC system, water system, equipment’s (Autoclave, Tunnel and Washer, Ampoule/Vial Filling Machine, Terminal Sterilizer, DHS, Holding Vessels, Compounding Vessels, Lyophilizer, LAF & Packing Equipment’s etc) and facility were Qualified. Media fill process simulation, process validation and cleaning validation of the facility were successfully performed.

·   Worked for cGMP Pharma ‘n’ Plans Pvt. Ltd. and handled project of newly established facility of GUFIC Lifesciences Pvt. Ltd., during the project phase of sterile injectables facility which includes the Validation and Qualification of following:

HVAC system, water system, equipment’s (Autoclave, Tunnel and Washer, Filling Machine, DHS, Lyophilizer & LAF etc) and facility were Qualified.

·   Worked for cGMP Pharma ‘n’ Plans Pvt. Ltd. and handled project of newly established facility of B. Braun (Ahlcon Parenterals: Green Field Project LVP/SVP Facility at Bhiwadi, Rajasthan) during the project phase of sterile injectables facility which includes the Qualification of equipment’s (Super-Heated Water Spray Sterilizer, Blow Fill Seal Machine, DHS, Lyophilizer, Filtration System, Vial Labelling machine, Visual Inspection machine & LAF etc), instruments, critical utility systems & facility.

·   Worked for cGMP Pharma ‘n’ Plans Pvt. Ltd. and handled project of newly established facility of Brooks Laboratories Ltd. Sterile Formulation Facility at Vadodara, Gujrat) during the project phase which includes the Validation and Qualification of following:

HVAC system, water system, equipment’s (Autoclave, Tunnel and Washer, Filling Machine, DHS, Lyophilizer & LAF etc) and facility were Qualified.

·   Worked for cGMP Pharma ‘n’ Plans Pvt. Ltd. and handled project of established facility of Sun Pharmaceuticals Industries Ltd. – Sterile Formulation Facility at Halol, Vadodara (Gujrat) during the project phase which includes the Qualification of HVAC system, FFM modules and facility.

·   Worked for cGMP Pharma ‘n’ Plans Pvt. Ltd. and handled project of newly established facility of Nika Pharmaceftika – Multiple Formulation Facility at Belarus, during the project phase which includes the Qualification of equipments, instruments, critical utility systems & facility.

·   Worked for Gulf Pharmaceutical Industries – Julphar and handled the project of newly established facility of Insulin Pen Filling Plant – Sterile Formulation Facility at Digdaga, Ras-Al-Khaimah (United Arab Emirates)-during the project phase which includes the Qualification of equipments, utility systems & facility.

• QMS and Auditing (Manufacturing & Supply chain sector)

1. Quality Management system implementation.
2. Quality Management SOP: – Preparation, review & implementation of SOPs.
3. In process control of process. Handling of market complaints, investigations.
4. GMP documents preparation and approval.
5. Participated in satisfactory Pharmaceutical manufacturing sector QMS audit of US-FDA, & supply chain regulatory audit of MOH-Qatar.
6. Lead satisfactory Internal Auditing/Self Inspections in Manufacturing sector.
7. Participated and lead satisfactory self-inspection & Principal audits (GSK, Sanofi & Bayer, etc..) in Pharmaceutical supply chain aspect of distribution sector – Qatar

• IPQA and Documentation

1. Giving line clearance for Batch to Batch and Product to Product.
2. Review of BMR / BFR/ BPR after completion of batch operation activity.
3. Performing In-process test during Batch Manufacturing, Filling and packing operation as per the frequency mentioned in SOP and respective Batch Documents.
4. Preparation of SOP as per the system requirement taking care of cGMP process.
5. Review and upgradation of SOP as an when required for betterment of the system.
6. Taking sample of Process validation and cleaning validation as recommended in the validation protocol.
7. Management of control sample as per study protocol and SOP’s.
8. Audit compliance and active participation in audits.
9. Preparation of Risk Assessment for equipment and critical utilities as per ICH Q9 (FMEA & FMECA).
10. Preparation of Validation Master Plan, Site Master File and Project Validation Plan.
11. Preparation of URS for all the equipments & instruments of Sterile formulation facility and containment systems.
12. Preparation and execution of complete qualification documents (i.e. DQ, IQ, OQ and PQ) of all equipments & instruments of Sterile formulation facility, Oral solid dosage facility and Containment systems.
13. Preparation of URS, DO, IQ, OQ and PQ of Critical Utilities such as HVAC system, Purified water system, Pure steam generation, WFI system, Compressed air system, Nitrogen generation system in compliance with various international regulatory guidelines.
14. Preparation of Process validation and Cleaning validation protocols for Sterile injectable facility.
15. Participated in Media fill for Process Simulation Study.

Handling of Software

1. Metric Stream (For QMS System)
2. LIMS (Control Sample & QC Management)
3. SAP System
4. DCS (Document Control System)
5. People Strong (HR management)
6. BMS (Building Management System)

Career Highlights

• Al Baironi Medical Store- Al Baker Group (Doha-Qatar)

The company mainly deals with Storage & Distribution of Pharmaceutical Products. They work closely with regulatory bodies such as Ministry of Health.

Designation: Quality In-charge

Experience: Aug. 2016 to till date.

• Gulf Pharmaceutical Industries – Julphar (UAE)

Julphar is cGMP compliant and has gained ISO9001 and 14001 accreditation, as well as EU-GMP and GLP certifications. They work closely with regulatory bodies such as Ministry of Health and US-FDA in order to ensure its practices are aligned with international requirements.

Designation: Asst. Officer- Validation & QA.

Experience: April. 2015 to May.2016

• cGMP Pharma ‘n’ Plans Pvt. Ltd., New Delhi (Consultancy Group)

The company mainly deals with the Conceptualizing, Designing, Engineering, Qualification/Validation and Quality Management System of various Pharmaceutical Projects.

Designation: Asst. Executive – Validation & QA.

Experience: Feb. 2014 to Apr. 2015.

• Fresenius Kabi Oncology Ltd.

An ISO 9001-2000, WHO, UK-MHRA, USFDA, TGA and ANVISA certified regulatory organization and its products have regulatory approvals in more than 30 countries across the world. The company strives to provide state-of-the-art third generation chemotherapeutic drugs (Anti-cancer drugs- injectables, oral cytotoxics, cytostatics, intermediates and Active Pharmaceutical Ingredients (APIs).) right from development to manufacturing & marketing across the globe.

Designation: Officer- Validation & QA.

Experience: Aug 2012 to Feb 2014.

Achievements

• Successfully completed project work at various sites of cGMP Pharma ‘n’ Plans as well as in my previous organizations i.e. Fresenius Kabi Oncology Ltd. and Gulf Pharmaceutical Industries (Julphar).

Academic Credentials

Qualifying Examination
Year of passing
Board/University
% obtained
Grade
B Pharmacy
2012
Himachal Pradesh university
76.00%
1st class

12th  (Medical)
2008
Punjab school education board
61.11%
1st class

10th  (All Subject)
2006
C.B.S.E. Board
50.00%
2nd Class

AREA OF INTEREST:

Ø  Quality Assurance department (Validation & Qualification, QMS, IPQA & Projects).

Ø  Production (Batch Operation & Production Planning).

Research Paper Published

Ø  ANTIHYPERTENSIVE EFFECT OF ETHANOLIC EXTRACT OF URTICA DIOICA L. LEAVES (URTICACEAE) IN RENAL ARTERY OCCLUDED HYPERTENSIVE RATS.  (Journal of Pharmacy Research Vol.5, Issue 7. July 2012, ISSN: 0974-6943)

Ø  ANTIHYPERTENSIVE EFFECT OF ETHANOLIC EXTRACT OF INDIAN CARICA PAPAYA L. ROOTS BARK (CARICACEAE) IN RENAL ARTERY OCCLUDED HYPERTENSIVE RATS. (IJPCR, July-September 2012, Vol 4, Issue 3, 20-23. ISSN 0975 1556)

Project

Ø I have done research work on kidney stone and develop in-vitro CSTTR Model on Kidney Stone.

Summer Training

Ø  Undergone one month training in “MDC PHARMACEUTICALS PVT.LTD”. Saproon, Baddi (H.P).

Personal Traits

§  A reliable and trustworthy individual with good interpersonal and communication skills.

§   A good decision taker with the ability to use own initiative and work well under pressure and gets on well with others, especially in a team situation.

§   Having Good motivative skill to motivate the person to complete the work within the stipulated time frame allotted.

§   Dedication in the work and respect the words of my seniors.

Computer Proficiency

§   Having satisfactory Knowledge of MS Word & MS Excel

§   Preparation of presentation in Power point.

§   Having good knowledge of internet.

PERSONAL DETAILS:

Full Name                              :           RAVI KANT THAKUR

Gender                                   :           Male

Date of Birth                          :           30 OCTOBER 1990

Nationality                             :           Indian

Marital Status                       :           Married

Domicile                                 :           Himachal Pradesh

Qatar Visa Status                  :           Valid and Company Sponsored

Language Proficiency           :           English, Hindi & Punjabi

Hobbies                                  :           Watching motivational videos & playing Cricket & Basketball

REFERENCES:

Ø Mr. Atul Sharma

Pr. Validation Engineer, Quality Assurance, Jacobs Engineering, Gurugram, Haryana.

DECLARATION:

I hereby certify that the information given by me in this document is absolutely true and to the best of my knowledge.

Date: 23 Feb. 2022
Place:  Doha -Qatar                           Ravi Kant Thakur