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RESUME
To,

Sub: - Application for the Suitable post in Quality Assurance / Drug Regulatory Affairs Department
Respected Sir,
I am enclosing herewith my detailed resume for your kind perusal, which I feel will be appropriate for your
company’s Quality Assurance / Drug Regulatory affairs requirement.

Name : SATISH CHAND SAINI

Father’s Name : Shri. Tejpal Singh Saini
Date of Birth : 1st June, 1969 (01/06/1969)
Nationality : Indian
Blood Group : AB +tive
Driving Licence No. : 117/P/95(N.004719) for Car / Scooter
Passport No. : Under process
Communication Address : S.C. Saini, House No. 36, Ground floor, Upasna enclave-Panditwadi,
Behind Siddhartha Paradise, Dehradun (Uttarakhand) –India, Ph. No.
09368132233, 0135-3243505 (Allotted Company flat)
E-mail Address : scspetrolab@yahoo.com / scspetrolab1@yahoo.com
Qualification : M.Sc. (Chemistry with 1st div.) (Specialization in analysis of Drug &
Pharmaceuticals and Fuel & Gas from (AIC)-Institution of Chemist
(India) Kolkata (WB).

: *PhD in (Anti-inflammatory -heterocyclic compound) from Meerut

University is under registration.

Additional Qualification : Diploma in “Quality Control & ISO- 9000” from AIMS-Madras.

: FDA Approved as analytical chemist (Chemical & Instrumental analysis)

Total Experience : Above 19 years

Salary Drawn : Rs. 12 Lac /- per annum + Family Accommodation

Expected Salary : Negotiable

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DETAILS OF EXPERIENCE
(1) Presently working with DCS/PLC based company M/s. India Glycols Limited “Ennature Biopharma”
(100%EOU) Dehradun (Uttarakhand) since May 2008 as “Head- Quality Assurance & Regulatory Affairs”.
The Company manufactures API’s / Bulk Drugs, Drug Intermediates, Dietary supplement products, Nutraceutical
Products by SCFE (Super critical Fluid Extraction, USA technology) and plans for product diversification i.e.
synthetic API & Formulations. The company is under accreditation by USFDA, TGA, MHRA, COS and WHO-
GMP certification.
www.indiaglycols.com

(2) Worked with a WHO-GMP, GMP, ISO 9001:2000 and COS awarded and USFDA /TGA/MHRA Projected
company M/s. CORAL DRUGS PVT. LIMITED, MURTHAL, SONEPAT (HARYANA) from June 2006 to
May -2008 as Sr. Manager (QA & DRA). The Company manufactures Steroid drugs, Anti-Cancer drugs, Anti-
diabetes drugs, Human Hormone drugs, Drug Intermediates and Nutrient Products (Herbal).
www.coraldrugs.com

(3) Worked with a cGMP & ISO 9001:2000 awarded (100%EOU) company M/s. GAURAV PHARMA PVT.
LIMITED, SAMPLA, ROHTAK (HR) from July 2004 to June-2006 as Manager (QA & DRA). The The
Company manufactures Anti-Cancer drugs, Antibiotic drugs, Steroid drugs, Human Hormone drugs, Drug
Intermediates, Nutrient Products (Herbal), Tablets, Capsule, Ointment and Parenterals.
www.gauravpharma.com

(4) Worked with a WHO-GMP, GMP, ISO 9001:2000 and COS awarded and USFDA /TGA/MHRA Projected company
M/s. CORAL DRUGS PVT. LIMITED, MURTHAL, SONEPAT (HARYANA) from June 2003 to July -2004
as Manager (QA & DRA). The Company manufactures Steroid drugs, Anti-Cancer drugs, Anti-diabetes drugs,
Human Hormone drugs, Drug Intermediates and Nutrient Products (Herbal).
www.coraldrugs.com

(5) Worked with a cGMP awarded Bulk Drug, Drug Intermediates and Fine Chemicals company M/s. PHOENIX
FINE CHEM PVT. LIMITED- SOHNA, GURGAON (HR) from November 2000 to May 2003 as Sr. Officer-
(QA & QC). The Company manufactures API’s / Bulk Drugs, Drugs intermediates and fine Chemicals.
www.phoenixfinechem.com

(6) Worked with DCS Based a large Petrochemical / Fine chemical company M/s. ATV- PETROCHEM LIMITED
-CHHATA, MATHURA (UP) from June 1995 to Oct. 2000 as Sr. Chemist - (QA & QC). The Company
manufactures P.T.A. (Purified Terephthalic Acid), and its derivatives with technical collaboration from AMOCO
(USA).
www.svcsuperchem.com

(7) Worked with DCS Based an ISO-9002 awarded a large Petrochemical / Fine chemical company M/s. HARYANA
PETROCHEMICAL LIMITED – REWARI (HARYANA) from June 1991 to June 1995 as Jr. Chemist – QC.
The Company manufactures P.E.T. (Polyethylene Terephthalate, its derivatives, Methanol, etc. with technical
collaboration from Enventa “EMS” Switzerland.
www.haryanapetrochemicals.com

(A) HANDELED LABORATORY INSTRUMENTS / EQUIPMENTS

HPLC (Quaternary-pump), GLC Head Space, UV-Visible Spectrophotometer, XRF, AAS, ICP, Color
Spectrophotometer, Hunter Color meter, Particle size analyzer, FTIR, GC-Mass, LC Mass, , K/F apparatus,
Melting Point Apparatus, Flame photometer, Wind monitor, Stack Monitor, Potentiometer, Polarimeter, Orsat Gas
apparatus, Conductivity meter, NTU Meter, Dissolution Apparatus, DT Apparatus.
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(B) RESPONSIBILITIES

(1) Planning and developing Quality Manual, SOPs, Validation Master Plan (VMP) and validation activities with
regulatory requirements.
(2) Supervising and timely review of regulatory / registration related technical documents i.e. Drug Master File (DMF)
DMF-CTD, COS, SFDA, Site Master File, Quality Manual and other regulatory documents for national and
international clients.
(3) Supervise about molecules characterization and elucidation of structure and its interpretation with the help of using
latest sophisticated laboratory instruments.
(4) Developing URS (User Requirement Specifications) with QC, R&D and Process Team’s plan for various products
and capacities.
(5) Ensuring about cGMP/WHO-GMP implementation in the plant. i.e. Management review meetings, CAPA
meetings, Investigation of OOS, Product recall, Change control, deviation control, Regulatory Inspection, Customer
Complaint, Annual Product Review, Document Control etc.
(6) Organizing the trainings as Training coordinator for various departments with various guidelines.
(7) Establishing the Quality Systems in accordance with international standards, regulatory process of APIs, filing
DMF’s Qualifications, validations, GMP/GLP Compliance and technical support to Marketing.
(8) Ensure about plant audit, approved vendor evaluation audit, internal audit and external audit with local or
International authorities.
(9) To redress customer complaints in timely manner and develop and adopt appropriate methodology.
(10) Filing product manufacturing permission applications and liaison with local FDA, filing of necessary reports for the
same.
(11) Prepare Layout design of new plant areas (for expansion) from the point of regulatory approvals like USFDA,
European, UK-MCA/ MHRA, ANVISA-Brazil and TGA -Australian regulatory authority’s requirements.
(12) Ensuring Installation, commissioning and start up of QC, Process and R&D Equipments with URS, DQ, FAT, SAT,
IQ, OQ and PQ requirements.
(13) Ensuring coordination and timely execution of water systems, process piping, clean rooms and EHS system.
(14) Supervising and involving with HAZOP Team for HAZOP study.
(15) Improve systems in order to reduce the gap between actual practice and documented procedure.
(16) Supervise about all types of stability studies of intermediates and final products as per ICH guideline.
(17) Ensure continual up-gradation of product quality improvement to World-class standards.
(18) Ensure product compliance as per the specifications prior to dispatch to customers.
(19) Establish and ensure about EHS (Environment health and safety), Process Hazard study, Risk Assessment for
each department.
(20) Ensuring and supervising handling and recording of AHU’S, Water System and Fire Safety System with
BMS systems as per required plant conditions.
(21) To reply vendor / regulatory queries related to facility and supplying of products.
(22) Preparing submissions of license variations and renewals.
(23) Developing and writing explanations for new product licenses and license renewals.
(24) Ensuring that company's products comply with the national and international regulations and standards.
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(C) KEY ACTIVITIES

(1) Attend daily P & Q meetings and discuss quality issues & resolve them.
(2) Submit reports to seniors as required in the pre-determined time frames, viz., MPR reports, Quality reports, etc.
(3) Make aware and share information on various aspects of production, pin development, quality, etc. with all persons
irrespective of department.
(4) To update on regulatory and statutory standards – Domestic & International.
(5) Ensuring cohesive team performance of the campus along with Head – Mfg. Operations.
(6) To keep abreast of development in computer technology and update recent additions.
(D) KEY COMPETENCIES
(1) Job knowledge – SPC & SQC
(2) Team leadership
(3) People development
(4) Knowledge of regulatory and statutory standards.
(5) Good communicator
(6) Training and development of QA, QC and ADL team.
(7) Implementation of SAP in each department
(E) OFFICIALLY TRAINED WITH FOLLOWING ORGANISATIONS / INSTITUTES FOR TQM

(1) M/s. German Remedies Limited, Mumbai

(2) M/s. Intas Pharmaceuticals Limited-Ahmedabad (Gujarat)
(3) M/s. Toshniwal instruments Pvt. Ltd. Nasik (Maharashtra)
(4) M/s. Institute of Frances petroleum (IFP) Mathura (UP)
(5) M/s. Indian Institute of Petroleum (IIP) – Dehradun (UK)
(6) M/s. Indian Petro-Chemical Limited (IPCL) - Vadodara (Gujarat)
(7) M/s Pharma Institute of GMP Pvt. Ltd. –Dehradun (UK)

(SATISH CHAND SAINI)

(This is a computer generated document hence does not need signature)