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Manager Manufacturing

Location:
Mumbai, MH, India
Posted:
September 08, 2016

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Resume:

Date: **/**/****

Permanent Address corresponding address

A-502, Mittal Tower A-1B Block Krishna apartment

Sector – 1, Plot 93 75D, Pachim Vihar West

Koparkhairane New Delhi-110063

Navi Mumbai-709 (INDIA)

Present Mobile : 887-***-****

TO,

HRD MANAGER

I am sending resume for the Position Chemical Engineer

I have 23 year experience in the API/AGRO-CHEMICAL/Pharma/Oncology industries as various positions. I have handled project execution, PPIC, Operations, QA, R&D, QC, process development, material Balance, Hydrogenation through Catalyst as Platinum Oxide, Platinum on Carbon, Raney Nickel & Ni-Al alloys, Scaling-up operation, Granulation, Compaction, Pellets and technology transfer to pilot plant to production & Documentation as batch monitoring record sheet, standard operating process, Water treatment Plant and Raw Material Sourcing & Procurement, Supply chain management (SCM) and vendor approval & developments.

I am enclosing my C.V. that will enlighten you on my educational and professional career.

Looking forward to our meeting at the earliest,

Yours sincerely

SIFAQUAT HUSSAIN

SIFAQUAT HUSSAIN

Mobile: +91-887******* ~ E-Mail: ********@*****.***, ************@*****.***

TOP MANUFACTURING PROFESSIONAL: 22.5 ears of rich experience

Manufacturing Excellence ~ Technology Transfer ~

Experience in the API / Agro-Chemical industry in Manufacturing Operations, Projects, Technology Transfer, Contract Manufacturing, Process Engineering and Dosage Forms (as Head and Executive Committee Member)

PROFILE SUMMARY

Pioneering experience in managing technically advanced, cost-efficient and state of the art production systems in Pharma industry; skilled in enhancing productivity, improving quality and achieving cost reduction;

expertise entails:

API Manufacturing Operations Plant Management Technology Transfer / Scale-up

Budgeting/ Cost Control Audits /Quality Assurance New Projects/ Set-ups

Materials & Inventory Management Regulatory & cGMP Compliance Utilities & Maintenance

New Product Development Validation Protocols/SOPs Team Leadership & Training

Expertise in heading regulatory inspections by agencies like MHRA, EDQM, USFDA, ISO 9000/9001/2000/2008 and vendor audit

A highly accomplished professional, spearheading manufacturing operations with key focus on top line & bottom-line profitability and optimal utilization of resources

Rich experience in all functions like technology transfer, production, projects and process engineering

Expertise in scale up, process enhancement, technology transfer of the API products and managing the complete operations entailing planning, resource utilization & manpower management

Experienced and working knowledge of pharmaceutical engineering projects such as design and implementation of controlled environments, capacity enhancement, plant expansion, incorporation of equipment and evaluation of manufacturing capacities at third parties.

Effective leader with excellent motivational skills to sustain growth momentum while motivating team performances in the organization

SKILL SET

Approved Manufacturing Chemist (Bulk Drug) from FDA Bangladesh

Capabilities in managing over 100 regulatory API (Active Pharmaceutical Ingredient's) as well as Agro-Chemical Products

Operational knowledge of Lab Instruments as UV Spectroscopy, HPLC, G.C., I.R. Karlfisher, Potentiometeric Titration, PH, TDS and Conductivity meter

Expert in PPIC and Supply Chain (Import & Export), Vendor Sourcing & approval of Chemical & machinery of Pharma & Chemicals industry

Successfully managed process development work for API and its intermediaries & drugs and technology transfer from R&D - lab to pilot scale production under GMP environment; undertook commercialization of approved products within budget

Managed documentation, execution of batches (scale-up, exhibit, optimization & validation)

WORK EXPERIENCE

July 16 to onward: Arora Matthey Ltd Kolkata India as Chief Operating Officer

Role:

Enhance the Quality & yield of Oncology API Platinum Based Products and coordinate the preparation of QC, QA, and Production document as per ICH guideline, Plant operations including API / Bulk Drug Manufacturing (all sites), Technology Transfer and Global Process Engineering operations and also Technical support of the Marketing & Business development department.

Support the Process engineering and New API Project erection.

Knowledge of Platinum & palladium Base Catalyst reprocess and reactivation.

Handle the vendor audit and Govt. audit local and international regulatory.

Feb’ 14 - May’ 16: Globe Drugs Limited, Bangladesh as Consultant-API

Role:

Steered complete array of operations including API / Bulk Drug Manufacturing (all sites), Technology Transfer and Global Process Engineering operations

Administered exhibit validation batches & launch support in API manufacturing for US, EU & other markets

Ensured compliance to cGMP, Global regulatory requirements and maintaining safety standards as per ISO 14000 and OHSAS 18000 for sustainable business, keeping the facility any time ready for inspection by external and internal audit

Spearheaded project management operations in state of the art manufacturing plants - from concept to commercialization for APIs and sterile dosage forms with lead role in design, technology transfers, audit preparations, hiring, training, team building.

Purchase raw Material & Machinery Sourcing & Procurement, Supply chain management (SCM) and vendor approval & developments.

Highlights:

Recognised for taking cost saving & process optimisation measures which led to significant savings & yield improvement like Amoxicillin trihydrate, Azithromycin, Ciprofloxacin, Flucloxacin Sodium etc.

Notable success in implementing a framework of Quality Standards, Procedures & Systems as per cGMP for API Operations; designed systems for safety of Operators and implemented engineering controls to avoid operator’s exposures to potent API

Feb’ 13 – Feb’ 14: Anuh Pharma Limited (R&D Centre), Mahape, New Mumbai, India

General Manager - Technology Transfer

Role:

Headed complete operations for set-up and implementation of manufacturing strategy and updated technology & process in line with organization strategy

Led technology transfer of products at manufacturing site and coordinated for activities site transfer by executing optimization, scale up & exhibit

Supported and interfaced with the Q.C. staff and management regarding of analysis of raw material and finished API products

Planned and executed process optimization, demonstration, validation, submission batches and site technology transfer products for regulated markets

Representing the company in front of the local and regulatory authorities.

Administered all operations of API / Bulk Drug manufacture as quality/compliance standards

Ensured proper co-ordination with Process Engineering / R&D for the scale-up of new processes

Highlights:

Notable success in Productivity Achievement & Process Improvement through maximum utilization of available resource with minimum rework and rejection; undertook measures Process Up gradation which led to cost saving of Products.

Proactively completed operational & process qualification of all equipment and area qualification in compliance to all the critical parameters; prepared all System & Departmental SOPs and ascertained compliance to the same

Drove continuous improvement activities on existing processes through change management process, best practices and updated new technologies

Prioritized and executed the product transfer activities to meet the product launch timelines effectively

Mar’ 12 – Feb’ 13: Gaurav Pharma Limited, New Delhi as General Manager Operations

Role:

Spearheaded entire gamut of manufacturing operations including production, process and quality assurance activities for timely delivery of API & formulations products to customers

Managed the operations as In-charge and supervised QC, QA, General Administration departments

Devised and rolled-out system for launch of new products, setting up co-ordination teams and conducting trials for ensuring successful transfer of new products from R&D to commercial production

Coordinated with maintenance team for smooth running of equipment and machinery

Identified opportunities for value addition to new product & process identification, process feasibility as well as economic analysis

Ensured proper functioning & control of quality assurance lab activities at the site

Prepared QA documents & maintained premises in clean state around the year to face audits

Highlights:

Delivered products (API) timely to the customers and achieved Manufacturing Excellence by robust method of production process and optimized the production cost

Acted as Senior Member of Company Executive Committee

Reduced product cost recovery by products through process development initiatives

Successfully represented the company in front of the local and regulatory authorities

Competently faced audits of EDQM, ISO and Vendor.

Set up the Technology Transfer department for streamlining the scale up process from R&D to Plant for successful commercialization

May’ 08 – Mar’ 12: Active Fine Chemicals Limited, Dhaka, Bangladesh as Vice President Technical & COO

Role:

Spearheaded plant operations to ensure timely completion of Bulk Drug production targets with 200 members within pre-designated time and cost parameters as per various regulatory guidelines

Liaison with various departments like QA, QC, Purchase, SCM, Engineering, Regulatory, F & D for the smooth functioning of the department

Provided guidance to Officers and Operators in Current Good Manufacturing Practices and Documentations of Tablet, Capsule, Sachet (Production & packing) Dosage Forms, as per norms of US FDA & WHO-cGMP guidelines

Ensured effective resource planning for optimizing manpower & machine utilization, reducing wastes as well as enhancing productivity and profitability

Managed import & export of Chemical & APIs

Designed, compiled and implemented Master Batch Documents, Standard Operating Procedures, Process Validation Protocol updating & implementation, Quality Manual and cGMP training modules

Highlights:

Implemented effective techniques to bring efficiency, quality & achieve maximum cost savings

Overall In-Charge Project from start to end & commercialization

Nov’ 05 – Apr’ 08: Thomas Baker Chemicals Limited, Mumbai as Senior Production Manager

Role:

Directed overall API operations at site; formulated production schedules for achieving the pre-defined production goals on time

Defined manufacturing target for 4 blocks and multiple product lines

Developed production plans & volumes, concepts for production optimization, yield improvement to ensure achievement of targets as per budgeted parameters

Prepared and allocated budget for CAPEX and raw material; monitored inventory for uninterrupted process

Headed execution of projects in time with cost reduction, yield, quality & capacity improvement

Ensured execution of work and documentation as per cGMP requirements in shop floor

Highlight:

Executed technology transfers at pilot & exhibit stage and led successful commercialization of projects

PREVIOUS EXPERIENCE

Nov’ 02 – Oct’ 05: Nem Organic Limited, Baroda as Technical Manager

Aug’ 00 – Mar’ 02: Orex Pharma Private Limited, Mumbai as Assistant Production Manager

Dec’ 97 – Jul’ 00: Alembic Chemicals Limited, Baroda as Production Officer

Sep’ 96 – Dec’ 97: Pan Drug Limited, Baroda as Shift Incharge

Jul’ 95 – Sep’ 96: DEE Pharma Limited, Bhiwadi as Shift Incharge

Apr’ 93 – Jul’ 95: Montary Industries Limited (Sister Concern of Ranbaxy Ltd.), Ropar, Punjab

Process Chemist

EDUCATION

1992 B.Sc. (Chemistry) from K.M.U, Nainital, U.P

PERSONAL DETAILS

Date of Birth: 15th June 1969

Passport Number: Z 2384209

Languages Known: Hindi, English, Gujrati, Bangli

Present Address: A-1B Block, Krishna Apartment, 75D, Paschim Vihar West, New Delhi -110063

Permanent Address: A-502, Mittal Tower, Sector – 1, Plot 93, Koparkhairane, Navi Mumbai - 400709

ANNEXURE ATTACHED

ANNEXURE OF API AND AGRO PRODUCTS

API Products

Menthol, Terpene, Pipermint,Trimethoprime, Sulphamethoxazole,Amoxycilline Trihhydrtae, Cloxacillin Sodium,, Flucloxacillin Sodium, Paracetamol, Erythromycin Stearate, Erythromycin Base, Erythromycin Propionate, Erythromycin 11,12, Carbonate, Erythromycin Estolate, Erythromycin Ethyl Succinate, Azithromycin, Clarithromycin, Roxythromycin, Ketrolac Base/Tromethmine, Rofecoxib, Fenofibrate, Mocolobemide, Venlaxfaxine Hcl, Chloroquine Sulphate, Chloroquine Phophate, Phenylpropanolamine Hcl, Amodiauine Base, Amodiaquine Hcl, Celecoxib, Fluconazole, Chromium Picolinate, Metformin Hcl, Pentoprazole, Nimesulide, Losartan Potassium, Ofloxacin, Levofloxacin,Ornidazole, Lumefentrine, Ambroxol HCL, Metoprolol Tartarate, Metoprolol Succinate, Moxifloxacin HCL, Pyrazinamide, Chloramphenicol Base And Palmitate, Telmisartan, Moxifloxacin Hcl, Cefexime Trihydrte, Ciprofloxacin HCL, Cisplatin, Carboplatin, Oxaliplatin

API Intermediate Products

CMIC Chloride, Trityl Chloride, 1, 4-Dioxane, Dane Salt, 4-AMINO -1, 2, 4-Trizole.4- (2-CHLOROETHYL) Morpholine HCL

Agro-Chemical Product manufacturing in our carrier

Isoproton, Chloropyrophose

Essential Oil Product

Essential Oil & Flavour Products as Menthol, Terpene & Menthone

Laboratory Reagent Product

Inorganic & Organic reagent, HPLC solvent & reagent, LC-MS & diagnostic reagent

Chemical Reaction

Friedel Craft, Hydrolysis, Oxidation, Hydrogenation, Reduction, Sulphonation, Dizotization, Oxidation, Acidification, Carboxylation, Chlorination, Bromination, Grignard, Esterification, Catalyst Reaction, Handle Platinum, Palladium Catalyst, Rainy-Nickel, Ni-Al Alloys and Recycle

Equipment Purview

S.S. Reactor, M.S. Reactor, Glass Line Reactor, Glass Column, Solvent Recovery Plant, Heat Exchanger, Centrifuge, Vacuum Distillation, Simple distillation, Azitropic Distillation, Hydrogenator, Tray, Fluid Bed Dryer, Compactor, pellets Coater, Vacuum Pump & Ejector, Vacuum Tray Dryer, Rotatory Vacuum Dryer, Sparkler Filter, Leaf Filter, Press Filter, Blender, Shifter, Air Jet Micronizer, Agitated Nutch Filter, Compactor, Air Compressor, Chilling plant, Brine plant Nitrogen plant, Hydrogen plant, Water Vacuum Pump, Oil Vacuum Pump, Steam Ejector and I.B.R. Boiler, Hot oil system. D.M/R.O. Water, Softener Water Plant, EDI RO.



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