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 Expert  724393

Expert in Pharmaceutical Engineering Maintenance, Calibration, Training, Safety System Implementation & Audits


Available for your Consulting and Expert Witness Needs

AP
India
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise:

Listed with other top experts in: 

As he has been the Head of Facility & Chief Engineer & Administration of world class standards,he was overall in charge of Facility Management of Medicorp's as well as Unit I & VI. Of Aurobindo's world class manufacturing facilities complying with regulatory requirements of USFDA,TGA,UK MHRA, WHO GMP etc.

His responsibilities, inter alia, included the following areas.

1.Maintenance & Annual Service Contracts: To organize preventive maintenance of equipments,Utilities and plants inclusive of HVAC, Cleanrooms, Computers ,Printers ,Servers. Programme maintenance contract with service providers for annual maintenance contracts etc. Budget and financial control for facility, utilities and Energy. 2.Statutory Liaisoning : Coordinate with statutory,regulatory and government agencies for compliance with applicable Acts and Rules of Electicity Boards,Directorate of Factories, Boiler Inspectorate,local govt.etc.

3.Energy Conservation : Implement energy conservation measures and water management procedures to minimize waste and cost control and work towards sustainable operations. 4.General Administration : Security, Transport, Canteen, Housekeeping, Pest and Rodent control, Landscaping & Gardening. 5.Communication & e- net work : Monitor and ensure 24X7 availibility of computer stations, hardware, software,servers, ERP / SAP networking, Lotus mails, intranet and internet access and control, working of telephone,fax, leased lines etc. Coordinate with service providers and help desk personnel. 6.Community Service : Interact with local community to maintain good rapport and public relations. Participate in industrial estate society matters.

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facility maintenance management

As he was head of safety in a pharmaceutical chemical plant he has formulated and prepared very detailed procedures for Gas cylinder Handling Safety addressing : SAFETY IN HANDLING, STORAGE, TRANSPORT AND USE OF COMPRESSED GAS CYLINDERS, to include IDENTIFICATION: , HANDLING & USE, PERSONNEL SAFETY, TRANSPORTATION OF CYLINDERS etc.
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gas handling safety

He is a qualified Internal Auditor for EMS ISO 14001. He was the Management Representative for implementation of Environmental Management System. It has been certified to the standard by BVQI with no non-compliances.This reflects his expertise in this field.
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ISO 14000 Environmental Management Standard

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ISO 14001 Requirements with guidance for use

He has extensively carried out safety audits of pharmaceutical plant laboratories and Bio-pharmaceutical Labs.He has prepared Lab. Safety Manual covering all aspects.
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laboratory safety

The manufacture of Active Pharmaceutical Ingredients (APIs) and finished dosage form drugs is a highly regulated industry. Guidelines of the World Health Organization (WHO), Good Manufacturing Practices (GMPs), the US FDA (as mandated by 21 CFR Part 11), and the International Conference on Harmonization (ICH) require establishing a Quality Management System with established Good Manufacturing Practices (GMPs). The above guidelines require the maintenance of process equipment, utilities, calibration of instruments and gauges, cleaning, and upkeep of buildings and facilities to prevent contamination, maintain validation of ventilation, air filtration, air heating and cooling systems. Also, critical systems like nitrogen, compressed air, and water used in the manufacturing process are required to be maintained, validated, monitored, and audited to ensure continuing process capability. These are essentially Maintenance Engineering functions and he possesses expertise in this area having worked as Chief Engineer for 7 years implementing procedures for the above functions and sustaining them by audits.
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maintenance engineering

Maintenance management is to formulate a maintenance plan and construct a control system to ensure the implementation of that plan. To accomplish this, an understanding of the nature of maintenance, its relationship with production, and the demands/expectations from the maintenance department are necessary. In other words, this calls for total familiarity with the situation for which he is responsible, recognition of the dynamic nature of the maintenance-production system, and understanding the mechanics of such a system. He possesses expertise in this function as having worked as Chief Engineer – Maintenance in a pharmaceutical manufacturing plant certified to US FDA regulations.
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maintenance management

The competency of the supervisor/workman to perform the given function may be by virtue of his technical education,training received, or skills developed on the job. The roles and responsibilities of each individual should be clearly defined to ensure accountability and achieve the objective.Identifying and implementing a training program is an essential part of developing a competent manpower for maintenance work. Training is necessary with changes in equipment, technology,and systems of work. A formal evaluation of training imparted and a documented system would ensure effectiveness of training. He has worked as Senior Instructor, Assistant Training officer and later as Head of Training implimenting training schemes and preparing a Training Manual.
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maintenance management training

Maintenance Planning is a continuous process of matching the resources of labor, materials, money and equipment with the need of the facility. Action oriented planning and controlling techniques are essential for daily maintenance management. The work schedule should be realistic and flexible enough for making allowances to the conditions as they actually exist in the plant. Hence, schedule changes should be expected. Planning for scenario based emergency breakdowns and assessing the time required for corrective action would help ensure that the objectives are met. In addition, the importance of adhering to the maintenance plan must be respected in both the production and maintenance departments. Communication between the departments must be good to enable an effective and flexible maintenance schedule. The maintenance plan, to a large extent, determines the level and nature of maintenance workload. He possesses expertise in this function as having worked as Chief Engineer – Maintenance in a pharmaceutical manufacturing plant certified to US FDA regulations.
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maintenance planning

As Chief Engineer and Head of Safety he established a sound Safety & Health Management System on OSHAS/ISO 18000 standards by providing resources and leadership. As head of Engineering process and Safety formalized Safety Policy, Conducted safety training as per training manual, Compiled Material safety Data Sheets for all chemicals and raw materials, organized prestart up safety during commissioning, Management of Change & change control procedures, Hazop Study and Risk assessment, root cause analysis, Emergency preparedness and response, mockdrills, Arranged for safety signs and posters to improve safety awareness, Prepared Plant Safety Manual, Laboratory Safety Manual & Bio safety manual, Implemented Safety Permit System – contract workers also included and trained, Conducted safety audit periodically, constituted safety committee, Arranged First Aid Centers and boxes, Documentation of Accidents and near miss accidents and incidents , Finalised PPE as per industry standards, Fire risk analysis done and augmented fire extinguishers and hydrant Points, Reorganised warehouse and storage practices, Procedures for Handling Compressed Gas Cylinders evolved. Safety color coding of engineering services, electrical safety and Static safety hazards addressed, earthing & grounding provided, Confined space entry procedures improved, safety in use of chemicals and spillage improved. As he was directly responsible for the above function he has the expertise in this field.

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occupational safety

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Occupational Safety and Health Administration

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safety management


Show Secondary and Basic Areas of Expertise

Education:
Year   Degree   Subject   Institution  
1969   5 year Engineering Apprenticeship   Elec. & Mech. Engineering   System Technical School  
1981   A M I E   Electrical Engineering   Institute of Engineers & Tech. London  
1999   P G Diploma   Utility Management   P G Institute of Energy Management  

Work History:
Years   Employer   Title   Responsibilities

2004 to 2007

 

Own

 

Consultant

 

He is a consultant on Engineering Maintenance, GMP Audits,Safety, Training Management, Safety Audits, Safety manual, Training manual

2002 to 2004

 

Aurobindo Pharma Limited, Hyderabad.

 

Chief Engineer – Engg, Safety & Training

 

He was responsible for GMP Audits, Regulatory training, Safety Management

1997 to 2002

 

Medicorp Technologies India Limited

 

Chief Engineer & Head of Safety & Env.

 

As Chief Engineer and Head of Safety, Health, Environment, Administration and Training, the following are the areas of responsibility : - Networking and Harmonization of different departments for taking over Project and Commissioning of Rs.500 Million Bulk Drug Plant Engineering systems to go into production mode. - Implementing Maintenance Management Systems. - Control of inventory of spare parts and purchase of spare parts. - Asset Budget Development & Management. - Calibration systems – monitoring and analysis - Implementing and sustaining ISO 9001 Quality Management System - Management Representative for implementation resulting in certification of ISO 14001 EMS - Recruitment - Training Co-ordination – identifying training needs, scheduling, programming and evaluation of training programs and development of skilled manpower - Established a sound Safety & Health Management System on OSHAS/ISO 18000 standards by providing resources and leadership - Risk Management : coordinated with insurance companies, TAC etc., to cover risks on errection and commissioning of plant, break-down, fire and public liability insurance. - Co-ordination with statutory, regulatory and Governmental agencies for compliance with applicable Acts and Rules. - Plant Administration – Time Office, Attendance, Wage Administration, Staff Welfare and grievances handling Facility management for regulatory audits like USFDA, TGA, UKMCA, WHO GMP, etc., of Medicorp's world class manufacturing facility.

1969 to 1992

 

Indian Railways

 

Asst. Mech. Engineer

 

28 years of managerial experience in electrical, mechanical and operating departments of Indian Railway System in Maintenance Management Systems, Technical Scrutiny of Projects, Tenders, Vendor Development, Training and Development of skilled manpower, utilization and accountal of assets, monitoring Performance and Crisis Management Special Experience : Repairs, Rewinding & Reconditioning of High HP Traction Motors & Generators.



Career Accomplishments:
Associations/Societies

ASSOCIATE MEMBER OF INSTITUTE OF ENGINEERS AND TECHNICIANS ( LONDON). MEMBER INDIAN INSTITUTE OF PLANT MANAGERS.

Licenses/Certifications

QUALIFIED INTERNAL AUDITOR FOR ISO 9000 QUALITY MANAGEMENT SYSTEMS. QUALIFIED INTERNAL AUDITOR FOR ISO 14000 ENVIRONMENTAL MANAGEMENT SYSTEMS. WORKED AS MANAGEMENT REPRESENTATIVE TO IMPLIMENT ISO 14000 ENVIRONMENTAL MANAGEMENT SYSTEMS

Professional Appointments

MEMBER OF DISTRICT CRISIS GROUP – PLANNING FOR AND PARTICIPATING IN OFF-SITE EMERGENGY PLAN. AS A MEMBER OF PASHAMYLARAM INDUSTRIAL AREA DEVELOPMENT SOCIETY COORDINATED FOR COMMON FACILITIES AND ECO- INDUSTRIAL DEVELOPMEMT.


Publications:
Publications and Patents Summary

My article “Maintenance Management – A process approach” has been published by International Society for Pharmaceutical Engineering, in their prestigious magazine “Pharmaceutical Engineering" in Dec. 2002. issue. My article “ Risk assessment approach for better compliance of GMP” has been published by CHRONICLE PHARMABIZ , South Asia's No.1 Weekly, June 23, 2005. issue.


Government Experience:
Years   Agency   Role   Description
1964 to 1992   Indian Railways   Mechanical Engineer   He has 28 years of managerial experience in electrical, mechanical and operating departments of Indian Railway System in Maintenance Management Systems, Technical Scrutiny of Projects, Tenders, Vendor Development, Training and Development of skilled manpower, utilization and accounting of assets, monitoring Performance and Crisis Management Special Experience : Repairs, Rewinding & Reconditioning of High HP Traction Motors & Generators.

Consulting Services:
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

International Experience:
Years   Country / Region   Summary
1979 to 1982   Zambia, Africa   On secondment from Govt. of India to Zambia Railways to train Zambian nationals in maintenance os locomotives.

Language Skills:
Foreign Language   Description
English   He possesses very high communication skills in both writen and spoken English.

Market Research:
- Implementing and sustaining ISO 9001 Quality Management System - Management Representative for implementation resulting in certification of ISO 14001 EMS - Established a sound Safety & Health Management System on OSHAS/ISO 18000 standards by providing resources and leadership - Risk Management : coordinated with insurance companies, TAC etc., to cover risks on errection and commissioning of plant, break-down, fire and public liability insurance.

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:
Training/Seminars

Safety Training Module. 1.General safe practices for all employees, Code of safe practice, Model policy statements, Why worry about safety – Safety is everybody's business. 2Cleanliness, Hygiene & Housekeeping, Hazard Communication. Slips, Trips & Falls. 3.Ergonomics, Material handling, Manual handling, Good handling techniques, Safe operation of cranes & forklifts. 4.Laboratory Safety – Why Lab Safety, Fundamentals of lab. Safety, Labeling & storage of chemicals, Incompatible chemicals, Hazard / Risk Phrases / Safety Phrases & Symbols. 5.Storage & handling of glassware. 1 6.Safety in handling, storage, transport, & use of compressed gas cylinders. 7.Color coding of engg. Services, hand tools, Compressed air, Pipelines, Machine guarding & power equipments. 8.Safe handling & use of Nitrogen. 9.Lab centrifuge safety & Autoclave safety. 10.Permit to work systems. 11.Personal Protective Equipment. 12.Electrical safety & static safety hazards. 13.Material Safety Data Sheets. 14.Fire Prevention & Protection. 15.First Aid & Emergency Preparedness. 16.Confined space entry, Lockout Tagout Procedures, Welding – cutting – burning. 17.Safety in the use of chemicals, Chemical spills, Health risks. 18.Incident reports, Near miss accidents, Accident investigation & reporting of accidents. 19.Bio Safety. Access, Personal Protection, Laboratory working areas, Laboratory design & facilities, Design features, Laboratory Equipment, Essential biosafety equipment, Waste handling, Decontamination & Sharps. 1. All training sessions would be of 2 hours duration. 2. Training methodology would be with the use of PowerPoint presentations. 3. One copy of training handout would be given in advance, photocopies of which may be made and given to all participants. 4. Two training sessions per day, namely, one session in the morning half from 10.30 to 12.30 hrs. and another session from 14.00 to 16.00 hrs can be programmed. Training can be arranged for 2 days per week. ie 4 sessions per week.

Supplier and Vendor Location and Selection

Technical Scrutiny of Projects, Tenders, Vendor Development,- Control of inventory of spare parts and purchase of spare parts. - Asset Budget Development & Management.

Other Skills and Services

Implementation of QMS ISO 9000-2000 Third Party Inspections. Vendor Development & Sourcing. SOPs for management systems.

Very high communication and Interpersonal skills. • Team building and getting results through others by consultative leadership • Systems approach and documentation. • Committed to improve environmental impacts on planet earth, thinking globally and acting locally. • Many control procedures prepared to prevent pollution of air, water and land.


 

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