SATISH CHAND SAINI

H. No. 36B, Groud Floor, Upasna Enclave, Panditwadi, Behind of Siddhrta Paradies, Dehradun, Uttarakhand-India, Tel. (Res.): +91 135-3243505, Mobile: +91 8057823065, 8057515187, email: scspetrolab@yahoo.com, satishcsaini@yahoo.com, Looking for leadership position in Petrochemicals, Fine chemicals and Active Pharmaceuticals, Nutraceuticals Substances where my expertise and rich experience can positively impact the organizations productivity and growth.

An Overview
Thorough understanding of technical aspects of the products & processes to the length of the regulatory requirement of products (US FDA, MHRA, TGA, KFDA, CEP, ISO9001:2008, ISO22000:2005, HACCP, Halal, ISO14000,Organic & other applicable regulatory bodies). An astute Quality professional with progressive cross-functional exposure to key function like Quality Control, R&D, Health, Safety & Environment, Quality Assurance, Regulatory Affairs and Customer Service in Petrochemicals, Fine chemicals and Active Pharmaceuticals, Nutraceuticals Substances Industries. Adept in executing of identification, technical evaluation of facilities, product qualification, negotiation (technical), technology transfer, product quality up-gradation and capacity enhancement of contract- manufacturers / Vendors. Identification & evaluations of vendors for our principal in the field of Petrochemicals, Fine chemicals and Active Pharmaceuticals, Nutraceuticals Substances industries. Extensive and progressive background in, Reviewing, Ensuring, Establishing XMP & other applicable Quality & Food Safety Management Systems at site as well as at contract manufacturers sites. Exposure in Petrochemicals, Fine chemicals and Active Pharmaceuticals, Nutraceuticals Substances at both National and International levels. Key member in new facility qualification as per global regulatory requirements in view of Quality assurance, Quality Control & Customer Service. Believe in participative, inspiring motivating coaching & sharing management to enhance the technical capabilities.

Career Contour
Presently working with DCS/PLC based GMP, Kosher, Halal, ISO9001:2008, ISO22000:2005, HACCP and Organic awarded company M/s. India Glycols Limited. Ennature Biopharma (100%EOU) Dehradun (Uttarakhand) since May 2008 as Head- Quality (QA, QC, EHS, DRA/Management Representative). The Company manufacturing APIs, Phytochemicals, Drugs intermediates and Nutraceuticals products, natural colours, standardized herbal extracts, flavours & fragrances and spice oleoresins for the beverage, dietary supplement, functional foods, pharmaceutical companies by SCFE (Super critical Fluid Extraction, USA technology) and plans expansion going for Herbal and Synthetic formulations. The company is under accreditation for, ISO14000, USFDA, COS/CEP and WHO-GMP certification. www.indiaglycols.com Worked with a WHO-GMP, GMP, ISO 9001:2000, ISO14000, COS/CEP and USFDA awarded company M/s. Coral Drugs Pvt. Ltd. Murthal, Sonipat HR, from May 2003 to May -2008 as Sr. Manager Quality (QA,QC,DRA,EHS). The Company manufacturing Anti-Cancer, Anti-Diabetic, Anti-Biotic, Anti-Asthmatic, Cortico-Steroids, Phytochemicals, Human Hormones APIs / Bulk Drugs, Drugs intermediates and Nutraceuticals products. www.coraldrugs.com Worked with a an ISO9001:2000, ISO14000 and GMP awarded company M/s. Gaurav Pharma Limited, Sampla, Bahadurgarh, HR from May 2001 to May 2003 as Manager Quality (QA,QC,EHS & DRA). The Company manufacturing Anti-Cancer, Anti-Diabetic, Anti-Biotic, Anti-Asthmatic, Steroids, Phytochemicals, Human Hormones APIs / Bulk Drugs, Drugs intermediates and Formulation (Tablets, Capsules, Ointment). www.gauravpharma.com Worked with an ISO-9001:2000 and GMP awarded Bulk Drug, Drug Intermediates and Fine Chemicals company M/s. Phoenix Fine Chem Pvt. Limited- Sohna, Gurgaon(HR) from November 1999 to May 2001 as Sr. Officer- Quality (QA,QC,EHS). The Company manufacturing APIs / Bulk Drugs, Drugs intermediates and fine Chemicals. www.phoenixfinechem.com

Worked with DCS Based an ISO-9002 awarded large fine chemical company M/s. ATV- Petrochem Ltd. Chhata, Mathura -UP from June 1995 to Oct. 1999 as Sr. Chemist - Quality (QA & QC). The Company manufactures P.T.A. (Purified Terephthalic Acid), and its derivatives with technical collaboration from AMOCO (USA). www.atvpetrochem.com Worked with DCS Based an ISO-9002 awarded a large fine chemical company M/s. Haryana Petrochemical Ltd. Rewari-HR from June 1990 to June 1995 as Jr. Chemist QC & QA. The Company manufactures P.E.T. (Polyethylene Terephthalate, its derivatives, Methanol, etc. with technical collaboration from Enventa EMS Switzerland. www.haryanapetrochemicals.com

Handled laboratory Instruments / Equipments

HPLC (Quaternary -pump), GLC Head Space, UV-Visible Spectrophotometer, XRF, AAS, ICP, GC Mass Spect. 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 etc.

Key Deliverables / Responsibilities

Lead a team and head the overall Quality Assurance & Drug Regulatory Affairs department for regulated markets for company products, ready to face international quality audits and get major approvals for the Company. Planning and developing Quality, Food safety and HACCP Manual, SOPs, Validation Master Plan (VMP) and validation activities as per global regulatory requirements. Oversee the quality assurance operations and services and ensure compliance to Current Good Manufacturing Practices (cGMP)/ USFDA /CEP/COS and other regulatory requirements. Oversee and approval of all types validations i.e. Facility Validation, Process Validation, Analytical Method Validation, Cleaning Validation, Personnel Validation, Water System Validation, HVAC Validation, Fire and Safety System Validation, BMS Validation. . Oversee and timely review of regulatory / registration related technical documents i.e. Drug Master File (DMF) EDMF-eCTD, COS/CEP, US-DMF-eCTD, FDA, SFDA, KFDA Site Master File, Quality Manual and other regulatory documents for national and international clients. Developing user requirement specifications with QC, R&D & Process teams plan for various products and capacities. Ensuring about cGMP, WHO-GMP, ISO9001:2008, ISO22000:2005, HACCP, Kosher, Halal implementation in the plant. i. e. Product Manual, Management review meetings, CAPA meetings, Investigation of OOS, Product recall, Change control, deviation control, Regulatory Inspection, Internal Audit, Customer Complaint, Product Recall, mock drills, Annual Product Review, Document Control, trend analysis, Out of Trend analysis etc. Organizing the trainings as training coordinator for various departments with various guidelines. Establishing the Quality Systems in accordance with international standards, regulatory process of APIs, filing DMFs Qualifications, validations, cGMP/GLP Compliance and technical support to Marketing Department. Ensure about plant audit, approved vendor evaluation audit, internal audit and external audit with local or International authorities. To redress customer complaints in timely manner and develop and adopt appropriate methodology. Filing product manufacturing permission applications and liaison with local FDA, filing of necessary reports for the same. 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 authoritys requirements. Ensuring Installation, commissioning and start up of QC, Process and R&D Equipments with URS, DQ, FAT, SAT, IQ, OQ and PQ requirements. Ensuring coordination and timely execution of water systems, process piping, clean rooms and EHS system. Supervise about molecules characterization and elucidation of structure and its interpretation with the help of using latest sophisticated laboratory instruments. Supervising and involving with HAZOP Team for HAZOP study. Improve systems in order to reduce the gap between actual practice and documented procedure. Supervise about all types of stability studies of intermediates and final products as per ICH guideline. Ensure continual up-gradation of product quality improvement to World-class standards. Ensure product compliance as per the specifications prior to dispatch to customers. Establish and ensure about EHS (Environment health and safety), Process Hazard study, Risk Assessment for each department. Ensuring and supervising handling and recording of AHUS, Water System and Fire Safety System with BMS systems as per required plant conditions. To reply vendor / regulatory queries related to facility and supplying of products. Preparing submissions of license variations and renewals. Developing and writing explanations for new product licenses and license renewals. Assess industry trends across all areas of cGMP and anticipate the needs of both the company and the customers and communicate these trends and appropriate options for the company to pursue. Foster advanced QA and QC methodologies to improve quality and compliance while simplifying processes to promote a quality-based, cost conscious, continuously improving and self challenging. Conduct product and process quality checks following established work instructions and sampling plans, and ensure that all products and processes meet the standards, Customer quality requirements, and regulatory requirements and regulatory requisites

Ensure about vendor approval/Qualification for using material, time to time vendor evaluation and vendor audits to check the required compliance at their site. Ensuring that company's products comply with the national and international regulations and standards. Work in a complex diverse and international environment to obtain solutions based on a solid background and understanding of the pharmaceutical industry. Proactively monitor sources of trends, complaints, failures, deviations and changes to identify opportunities for system, process and product improvements.

Key Activities
Attend daily P & Q meetings and discuss quality issues & resolve them. Submit reports to seniors as required in the pre-determined time frames, viz., MPR reports, Quality reports, etc. Make aware and share information on various aspects of production, pin development, quality, etc. with all persons irrespective of department. To update on regulatory and statutory standards Domestic & International. Ensuring cohesive team performance of the campus along with Head Mfg. Operations. To keep abreast of development in computer technology and update recent additions.

Key Competencies

Job knowledge SPC & SQC, Team leadership, People development and Good Communicator. Knowledge of regulatory and statutory standards. Positive and professional attitude with a very pleasant personality matched with the ability to manage stress, time and people effectively A good team player with an ability to lead a team by example and motivate them to achieve desired objectives Expert in Crisis management & turn around management operations Held different positions in the key functions, strengthen the basic understandings of the complete product life cycle. ( from Vendor to Customer) Nominated as Management Representative within organization for Quality Management System & Food Safety Management System and to contract manufacturers on topics related to GMP & Safety. As additional responsibility develop Training Manual & Training Module to give trainings on GMP. Implementation of SAP in each department Member of India Glycols Limited Green Team.

Professional Training Attended with following Organizations

M/s. German Remedies Limited, Mumbai (Maharashtra) M/s. Intas Pharmaceuticals Limited-Ahmadabad (Gujarat) M/s. Toshniwal instruments Pvt. Ltd. Nasik (Maharashtra) M/s. Institute of Frances petroleum (IFP) Mathura (UP) M/s. Indian Institute of Petroleum (IIP) Dehradun (UK) M/s. Indian Petro-Chemical Limited (IPCL) - Vadodra (Gujarat) M/s Pharma Institute of GMP Pvt. Ltd. Dehradun (UK)

Scholastics

PhD is under appearing in Chemistry. M.Phil (Chemistry Research) with 1st division (75% marks) M.Sc. (Analytical Chemistry) with 1st division (70% marks) Diploma in Quality Control & ISO- 9000 from AIMS-Madras. Approved Analytical Chemist (from State Drugs Control Authorities, Haryana, Uttarakhand)

Personal Vitae
Father Name : Shri Tejpal Singh Saini Date of Birth : 1st June 1969 Marital Status : Married, blessed 2 kids Passport: Under Process (Expected in the month of September-2011) Driving Licence: UA-0720110143397(Valid up to 2019) Blood Group : AB (Positive) Skype ID : scsaini4 Total Experience: Above 21 years. Current CTC : Rs. 15 LPA + Family Accommodation and other facilities Expectation : Negotiation

Departmental Hierarchys My Self

Managers Dy. Mangers Asst Managers Sr. Executives Executives Asstt. Executive Notice Period: Minimum Three Month or one month if remaining two month notice period bough out by company

Official Reporting System

Directly Reporting to Chairman and Managing Director (CMD) through President / Vice President Plant

Professional and Personal References

Will be provided on request.

Satish Chand Saini