Engineering Head - Injectibles

Site controller, hold authority to implement various systems in the department, an active member in Quality circle, energy management team, EHS, a lead auditee for the engineering department having faced many Regulatory, Customer and Certification audits.

An elaboration of a few roles are below : Energy management :

- Introduced a system of continual focus on energy management by linking it to objectives, evaluation of individual's performance based on achievement of his objectives. This has resulted in phenomenal controls on energy consumption. Sphere headed multiple Energy management programs on black utility, clean utility and direct energy savings Green initiatives : ODS management schemes,

- Rain water harvesting, waste reduction and effective treatments, various kinds of waste management systems and working on Carbon credits scheme. Project handling and management :

- Have independently handled various small to medium size projects that involved facility expansion, up-gradation and retrofits. Some projects worth mentioning are on facility for downstream processing of insulin, MAB's, Fill finish facility and a facility for injectable API.

- Clean utilities : Experienced on installation and maintenance of all clean utilities like hot WFI, ambient WFI, purified water system, PSG, loops, documentation , regulatory requirements etc. HVAC : S

- Strong knowledge on various types of HVAC systems their operation, maintenance, validation and regulatory requirements. Co-ordination for Continual improvement programs on TQM, Kaizen, GEP, active member of quality circle, trainings of personnel, chalking induction and job orientation programs for new recruits.

- Carrying out Engineering analysis on equipment - decision of replacement, Downtime , MTTR, MTBF, Plant uptime analysis, condition monitoring for equipment, predictive analysis. Environment Health and Safety :

- Responsible as a Site controller for all accidents and incidents, emergency situations arising in the plant. Identifying process hazards, ( HAZOP studies) , Emergency response system, risk mitigation for equipment and plants, OHSAS management systems, first aid, rain water harvesting etc...

- Documentation and Audits : This has been a key area of my contribution towards laying in systems for Equipment - Facility qualification , validation, preparation of SOP's , CAPA, methods of handling deviations and their controls. Also, have been a lead auditee for the engineering department for Regulatory Customer and Certification audits. Have faced many audits directed towards facility and products from USFDA, MCC, TGA, ANVISA, JFDA etc.

- Also function as a internal auditor for the department. Cost management and control :

- Preparing CAPEX and revenue budgets for the department.

- Tracking, Controlling & Maintaining the expenses trend of the revenue for the department month wise. Inventory management and control :

- Maintaining only critical spares at the same time keeping the inventory costs low by substituting the -imported spares with Indigenous developed spares without compromising quality

- Ensuring a healthy inventory hold system by not having dead inventories.

Training : Implementation of training programs.