SUMMARY

Experience in Quality Control as well as Quality Assurance and Regulatory Affairs

Department in reputed Pharma industry of Pharma & Herbal /Ayurveda, Cosmetics.

Exposure of working with ISO 9002, GMP / WHOc GMP,GLP, ARMY Audit organization.

Handling and conducting Drug Authority Inspection, Correspondence of Drug Related Data.

Preparation of Drug Master File of approved product for registration of product in AsianCountries ie Nepal, Burma, Mayanmar, Srilanka,Ghana,Kenya,Ethopia,Malta,Kenya and Philippines, Ghana, Brazil,BMR/BPR,STP/SOP/OOS,CAPA.IHS, Validation & calibration

APPROVAL: Approved in Chemical, Micro and Instrumentation Analysis of Drugs from Directorate General of Health Services- Chandigarh, Govt. of Haryana. / Delhi & Himachal Pradesh.

EDUCATION

1. B. Pharmacy from Gulburga University Gulbarga in 1991 -1995.

Diploma in QUALITY MANAGEMENT & ISO SERIES from Bangalore in 1997-1998..

3. 10+2 with Physics, Chemistry, and Bio from C.B.S.E Board in 1991.from, MADRAS.

4. 10 with science from, CBSE New Delhi in 1989.from Central School, ASSAM.

5. Passed Diploma in Hospital Management / Export/Import management from Agra and studying

MBA in International Business Management from Pondicherry University 1998 – 2001.

PROFESSIONAL EXPERIENCE Presently working with:

Asia biotech Pvt Jaipur from Dec 2016 …… It is a Allopathic & Ayurvedic Herbal based

company engaged in the mfg of Tablets, capsule, cream/lotion and Syrups from Past 2

year. Under process for WHOcGMP / ISO Accreditation inspection for export in Asian

Countries. As Manager Quality Control, Assurance & Regulatory Affairs.

* Worked with Quixotic Healthcare Baddi (H.P) as Manager (Q.A & R.Affairs) from 15

August 2015 to Nov 2016 Company is engaged in the mfg of Liquid & Dry Syrup,

Injectable for reputed company of Pharma, i.e Sister Concern of Legency Remedies.

Wockhardt ltd, Intas Pharma, Coles Pharma, Zen labs Canada, Khandelwal labs, Medley

Labs,Helio Pharma, Parabolic Drugs Ltd and many more are expected to have an Audit

of MNC Pharma Companies of Baddi for next financial year .

.

VSD LIFE SCIENCE, (H.P) – BADDI (GMP / ISO 9002 Accredited.)

The VSD LIFE SCIENCE is based in Baddi. The state-of-the art manufacturing plant is approved by ISO 9002 and GMP authorities. The company is manufacturing a wide range of formulations like

Tablets, Capsules, Syrups, Liquid orals and Eye Drops .

Mfg : Tablets, Capsules,Liquid and Eye Drops.

Duration: June 2013 10 August 2015.

Designation: Asst Manager-Quality Assurance & Regulatory affairs

Job Profile: Responsible for overall activities of General QA Functions, Dossier prep,. DCI documents for approval of new Drug, Drug office correspondence, Preparation of MFR /BPR, SOP/ STP as per WHOcGMP / GLP guidelines.

F CYPER PHARMA – NEW DELHI (WHOcGMP / ISO 9002)

Mfg Tablets and Capsules

Duration: Janurary-2009 - June-2013

Designation: Senior Executive Quality Assurance. & Regulatory Affairs.

Job Profile: Calibration, Validation, In-Process Checks Controls, and Internal Audit Team & as a Documentation Coordinator. Process validarion,Stability studies.

F PSYCHOTROPIC INDIA LTD – FARIDABAD (WHOcGMP accede)

Mfg Tablets, Capsules, Liquid, Medicated Soaps & skin cream/Powder

Duration: December -2005 – November -2008

Designation: Sr Quality Assurance / Control Executive.

Job Profile: Specification of Finished Products, Raw Materials, Intermediate Products, Instrumentation calibration & validation, and Documentation.

Preparation of all documents as per third Party specification, conduct trial lot

And finally to commercial level,SOP,STP/ STS,CAPA,AUDIT and MFR.

F BELCO PHARMA - NEW DELHI (WHOcGMP accd.)

Mfg Tablets, Capsule, liquids, Injection/ Eye drops, &Ointments /lotion.

Duration: October-2003 – Oct 2005

Designation: Approved Analytical Chemist, (Sr. Q.C chemist) / Q.C Incharge.

Job Profile: Testing of Raw Materials, Packaging Materials, Various stages of water, & Documentation’s per international norms, STS/STP of RM / PM.

- UNISULE LABS - SONEPAT

Mfg Tablets, Capsule, Injection, Eye & Ear Drops and liquid.

Duration : August 2002 - Sep 2003

Designation : Asst Chemist

Job Profile : looking after Packing Department, documentation of BPR,Raw material store.

SPECIALIZED AREA OF FUNCTIONING:

Job Responsibilities: Quality Assurance

. Documentation and Process Development of Herbal & Ayurvedic drugs for Tablets, Capsules, Oils, lotion/Ointments, and Cosmetics.

QA Documentation: Review, preparation, maintaining and tracking of documents, to keep documents up-to-date according to current regulatory requirements. Update and/or revise BMR/BPR as per Schedule U of Drugs and Cosmetic Act 1940, Review of BMR/BPR received from production after completion of activity, and test records from Quality Control are received and available for released the product.

Handling of Market/Customer Complaints: Tracking, logging-in, processing, recording/obtaining necessary information, and providing a written and/or verbal response to each complaint.

Training Facilitator: To provide and maintained the training records of GMP, GDP, Schedule M and other regulatory/in-house training to plant personnel.

Vendors & Internal Audits: Assist / perform supplier and contract manufacturer audits as and when required. Co-ordinate/perform required internal audits within the plant of various departments.

Change Control and Deviation Control Process: Through the Change Control Process, circulate, maintained and implement the records and information to various department/authorities.

Calibrations and Validations: Review of calibration and validation parameters and implementation. Review of the calibration schedule, calibration matrix. In-house calibration of entire plant. Prepare process validations protocols and reports, Prepare and review of equipment qualification protocols, cleaning validations protocols and process validations.

Coordination with other departments: Interaction with all departments and to keep management team abreast of departments issues or developments and actions taken for improvements.

Preparing Dossier and responsible for product registration in different Countries.

Coordinate with manufacturing locations and various departments of R&D for requisite data generation and subsequent filing in respective countries.

Review, evaluation and submission of dossiers (Formulations) to different countries.

Responsible for timely delivery of dossiers as per strategy plan.

. Knowledge of compiling Dossiers in different formats such as PDF, CTD and eCTD formats.

. Preparation of departmental SOPs, Protocols, & validation documents

. Supporting Regulatory Documentation of Agencies like MHRA /USFDA.

. Maintenance of Regulatory Database Management System or any other requirement .

. Updating of Requisite Regulatory Information & Guidelines of Regulatory Authorities of

various Countries to ensure preparation of Quality Dossiers.

. To maintain & update database for easy Retrieval of Documents and Information

Knowledge of Artwork Approvals for various Countries as per Marketing Requirements/Guidelines.

Job Responsibilities: Quality Control

Analytical Division: Analysis of most of the active Raw Materials and packing materials, used for formulation. Analysis of finished products.

Instrumentation: Handling of sophisticated instruments like HPLC, and IR. Handling of general instruments like UV-Visible spectrophotometer, KF auto-titrator, Polarimeter, Refractor meter, Photoflurometer, AAS, and Colorimeter.

COMPUTER SKILLS:

Package: MS-Office all versions.

Operating System: Windows all versions.

Adobe Photoshop, PageMaker,

General maintenance of PC and Software uploading.

CURRICULAR ACTIVITIES:

Documentation of Documents as per GMP/ GLP, WHOc GMP & ISO 9002 series.for Allopathic herbal,ayurveda medicines and cosmetics.

As a facilitator to provide the training for production associates on WHO-GMP, GDP, and requirements of Schedule M.

Preparation of Dossiers of Products Registration in exporting Countries.

Attended the seminar on Stability Studies of Products as per FDA norms.

Granted WHOcGMP for 24 products ( II nd company in Haryana to have WHOcGMP accd)

PERSONAL PROFILE:

Fathers’ Name: Sri. P.S. Johri (Ex-Defence Officer in IAF AGRA)

Mothers’ Name: Smt. Kamla Johri (House wife)

Permanent Address: 119/120 MV Colony Sahagang, Agra (U.P) India. .

Date of Birth: 15nd August-1973

Marital Status: Married Nationality: Indian

Place -- DRx Pavan kr Johri (RPh)

Contact this candidate