Industrial Training Plant

CURRICULUM VITAE

AMIT MALVIYA

B.E. (Instrumentation)

Mob: 990-***-****

Email: *.********@*****.***

Job Synopsis:

* ****+ Experience in PHARMA industry as Electrical & Instrumentation Maintenance.

PLC, HMI, SCADA and automation systems Maintenance.

Electrical Distribution & Control system, Maintenance, Installation.

LT/MCC panels, ACB, Switchgear, PCC to DG change over system.

Documentation: QMS, Validation, etc.

ORGANIZATIONAL EXPERIENCE:

1)Worked with Cadila Healthcare Ltd., Ahmedabad since June 2020.

Designation :Sr. Executive in Engineering Department

Dosage Form: Tablet/Capsule Plant

2)Worked with Cipla Ltd., Pithampur [USFDA approved plant] From January 2019 to January 2020.

Designation : Sr. Executive in Engineering Department

3)Worked with Piramal Enterprises Ltd., Pithampur [USFDA,MHRA, ANVISA(Brazil), ISO14001 approved plant] From September 2015-December 2018.

Designation : Executive in Engineering Department

Dosage Form: Tablet/Capsule Plant

4)Worked with IPCA Laboratories Ltd., Pithampur [USFDA,MHRA, ANVISA(Brazil), ISO14001 approved plant] From Jun 2012 to Sept 2015

Designation : Junior Officer in Engineering Department

Dosage Form: Tablet/Capsule Plant

5)Worked with Medgel Pharmaceutical Pvt. Ltd., Pithampur From Mar 2011- January 2012.

Designation : Asst. Engineer in Utility Department

Dosage Form: Capsule Plant

Job Responsibilities:

Preventive Maintenance, Diagnose & Troubles shoot problems of PLC, HMI, SCADA and automation systems, LV Soft Starters, Control & Protection Relays, Transformer.

Scheduled and corrective maintenance of Transformer, MCC/PCC panels, DG Sets up to 1000 KVA, ACB (Air Circuit Breaker) Maintenance, motors, Troubleshooting for Electrical, Control Panel accessories like VFD, starter, contactor, relay, Switchgear etc.

Handle all Electrical & Instrumentation Systems for Utility, Water system, HVAC & Plant machines, PCC to DG change over system.

Responsible for new machine installation, utility arrangement.

Install & maintain electric panel, control panel, wiring, etc.

Power Factor controlling, and maintenance of APFC panel.

Installation, Preventive & Breakdown Maintenance of UPS up to 40 kVA.

Handle the maintenance/Troubleshooting of all process Instruments like I/P converters, pressure switches, pneumatic control valve positioner (Linear & Rotary type), (Direct & Reverse Acting), Actuators, solenoid valves.

Handle the Calibration and maintenance of all process Instruments etc.

Handling Operation and maintenance of BMS (Building management system) and ACS (AHU Controlling System).

All documentation required for schedule and maintenance work as per regulations, statutory compliance and Safety Standards.

To prepare the Preventive maintenance schedule, checklist for the plant equipments/ machineries and Utility ( Air compressor, Chiller) machineries.

Identify CAPA for all quality/safety incidences, using root cause analysis tools.

Ensure all National Electricity regulation requirements are met through design, installation and maintenance of electrical installations.

Handle Installation and Operation of AC Drives (VFD).

All documentation required in department for schedule and maintenance work as per GMP and Safety Standards.

Handle Operation and Validation of Equipments and all documentation work related to it like Validation, Qualification (URS,DQ,IQ,OQ,PQ) protocols, Reports etc. as per cGMP & 21CFR standards.

Temperature Mapping and all documentation activities required as per cGMP standards.

Maintain critical spare part stock of machines, raise purchase requisition using SAP and take follow up from vendors. Indenting and ensuring minimum inventory for critical spares.

Prepare the SOP’s (Standard Operating Procedure) of Engineering department and periodic review of SOP.

Maintain documentation as per SOP and cGMP standards and Giving on job training as per training schedule and maintain its record.

Prepare the JSA (Job Safety Analysis), HIRA (Hazard Identification and Risk Assessment) for various job roles of engineering.

Handle RCA (Root Cause Analysis) activities.

To look for the for breakdown free continuous operation.

Responsible for assisting team technician under supervision.

Handling of equipment (Autoclave, Filling lines, Mixing vessels.)

Development & troubleshooting in Computer system Compliances & reports generation.

Documentation:

QMS, Change Control, Deviation, PLC Validation, Equipment Validation, SOP Revision, SOP Training, etc.

Calibration:

All documentation required for Calibration activity As per schedule. Preparation of calibration schedule, SOP. Maintain calibration document of master instruments. Working on following instruments & their calibration:

1)Temperature: Temperature Controller, RTD, Thermocouple, Temperature Transmitter, Temperature Recorder.

2)Pressure: Pressure gauge, Differential Pressure Transmitter, Magnehelic gauge, Vacuum Gauge, Static Pressure.

3)Flow Meter: Rotamemer, Differential Pressure type, Electromagnetic, Vortex.

4)Level: Capacitance method, Differential Pressure type, Measurement by Ultrasonic & Radar Pulses.

5)Other: Load Cell Calibration, Air Velocity Sensor, Conductivity Meter, Humidity Sensor, RPM.

Maintenance –

Responsible for Electrical & Instrumentation Maintenance (preventive, breakdown) of following machines of Production department:

S.No.

Department

Machine Name

Make

1

Granulation

Fluid Bed Processor

Glatt, Alliance, Pam Glatt, Ace, Anish, Kevin

2

Rapid Mixer Granulator

Tapasya, Bectochem

3

V Blender

Saan

4

Co-Mill with Vacuum Transfer System

Ganson

5

Capsule Filling

Capsule Filling

ACG PAM, Adapta (IMA), MG2

6

Compression

Tablet Compression

Korch, Fette, Cadmach (CPD IV, C300, C200 CTX), Sejong (HRC, MRC)

7

Coating

Coater

Glatt, L.B. Bohle, Kevin, Sejong (100,150,170 SFC),

8

Packaging

Bottle

CVC

Blister

BQS, IMA PG

And Labelling, Cartonator, Strip packing, Shrink wrapping, Shipper Strapping, Serailization system

PLC Validation:

The conformation of status of PLC/computer system of machine/ equipment that whether they are complying the regulations of GAMP & 21 CFR Part 11. This includes:

1)Computer System Gxp And Part 11 Evaluation

2)Traceability Matrix With Risk Assessment (Tmra)

3)Computer System Validation Plan (Csvp)

4)Qualification Protocol

4.1) It includes preparation & execution of:

a)Installation qualification protocol (IQP)

b)Operational qualification protocol (OQP)

c)Performance qualification protocol (PQP)

4.2) It includes verification/ testing of:

a)Functional checks of analog &digital input & output of PLC.

b)Access control / security level

c)System Hardware & Software

d)Range & Boundary Tests of set parameter

e)Power failure & communication failure conditions

f)MMI/ SCADA screen verification

g)Interlocks & Alarms

AUDIT EXPOSURE:

Well versed with regulated environment and faced several regulatory Audits like USFDA, MHRA(UK), ANVISA(Brazil), ISO14001, TGA(Australia), WHO(Geneva), and Customer Audits.

ACADEMIC DETAILS:

Examination

Board/University

Percentage %

Year

B.E. (IC)

RGTU, Bhopal

60.41

2010

H.S.C.

M.P.B.S.E., Bhopal

76.22

2004

S.S.C.

M.P.B.S.E., Bhopal

72.60

2002

COMPUTER PROFICIENCY:

Functional user of SAP (MM, PM, CALIBRATION module).

Documentum D2.

MS Office Suite and Operating System viz. Windows XP, 2000, 2003, 2007.

INDUSTRIAL TRAINING:

30 days training from R. K. Electronics, Indore (M.P.).

QUALIFICATION PROJECT:

Major : Design of Agriculture Robot based on microcontroller .

Minor : Auto on-off Emergency Light with self charger.

EXTRA CURRICULAR ACTIVITY:

TQM (Total Quality Management) Department Representative in Ipca, Pithampur.

First Aid Training at Ipca, Pithampur.

Participated in “Do you know” under the national level technical festival “Ingenious 08” organised by SVITS.

PERSONAL PROFILE:

Date of birth : 13th Dec 1987

Marital Status : Married

Address : Sanawad(M.P.), District: Khargone.

DECLARATION:

I hereby declare that all the details furnished above are true to the best of my knowledge.

Date:

Place:

(Amit Malviya)

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