Expert Details

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

Expert ID: 724393 India

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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.



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.


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.


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


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.


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.


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.

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.


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.



Education

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

Work History

Years Employer Title Department Responsibilities
Years: 2004 to 2007 Employer: Own Title: Consultant Department: Responsibilities: He is a consultant on Engineering Maintenance, GMP Audits,Safety, Training
Management, Safety Audits, Safety manual,
Training manual
Years: 2002 to 2004 Employer: Aurobindo Pharma Limited, Hyderabad. Title: Chief Engineer – Engg, Safety & Training Department: Responsibilities: He was responsible for GMP Audits, Regulatory training, Safety
Management
Years: 1997 to 2002 Employer: Medicorp Technologies India Limited Title: Chief Engineer & Head of Safety & Env. Department: Responsibilities: 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.
Years: 1969 to 1992 Employer: Indian Railways Title: Asst. Mech. Engineer Department: Responsibilities: 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.

Government Experience

Years Agency Role Description
Years: 1964 to 1992 Agency: Indian Railways Role: Mechanical Engineer Description: 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.

International Experience

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

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 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.

Additional Experience

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

Language Skills

Language Proficiency
English He possesses very high communication skills in both writen and spoken English.

Fields of Expertise

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