Curriculum Vitae

D-301,Mohan Palm, Badlapur East ,Dist. Thane

Cell No. 09823382808
Email ID: ashishmali28@gmail.com

Professional Summary
 B.E. in Chemical engineering and nearly 18 years of experience in
Production Operations, Project and process engineering.
 Skilful and effective handling of audits to achieve the desired results
for organization.
 Possess domain expertise in production operations including planning
and executing them by following GMP and Safety procedures
guidelines.
 Foreseeing performance bottlenecks and taking corrective measures to
avoid the same.
 Effective communicator with management skills & strong analytical,
problem solving abilities.

Core Competencies
Production Planning & Control
 Developing new process concepts for production optimization, yield
improvement and develop guidelines for the sequencing of
manufacturing activities on the shop floor.
 Minimizing performance bottlenecks for achieving high productivity
with minimum consumption of material & machine and monitoring
expenses.
 Faced various regulatory audit like USFDA and EDQM and WHO GMP
 Coordinating with Stores, Q.C, Q.A, Maintenance, and P.D .lab in day-
to-day activity for better operational conditions
 Preparation, reviewing and implementation of SOP’s.
 Preparation and reviewing of BMR’s.
 To investigate critical deviations and record the conclusions
 Worked on initiating and processing of Temp Change control and
Change control.
 Ensure quality of all products and intermediates are as per the defined
standards
 Preparation of daily and monthly production reports
 Involving in Process validation and cleaning validation.
 Setting up production targets and achieve the same within time and
cost parameters.
 Worked on SAP/ERP Module.
 Overseeing production related tasks including planning, control and
trouble shooting
 Optimising man & machine utilisation to achieve pre set production
targets.

Project Engineering and Process Engineering

 Preparation of User specification requirement (USR)

 To make PFD, P&ID, material balance, energy balance, equipment
sizing, getting quotations, installation and commissioning
 Involving in preparing, IQ, OQ and PQ for the new project.
 Involving in FAT and SAT for the Equipment.
 Involving in Installation and commissioning of Reactor, Centrifuge,
Dryers Pumps and filters.
 Preparing Cost Estimates for the project.
 Detail planning and schedule of project for all stages (Engineering,
Procurement & Construction) and keeping track continuously with it.
 Have done Time Cycle Studies TRT (Turn round time) calculation,
Trouble shooting De-Bottle necking, Process optimisation.
 Prepared HAZOP Study report for new product

People Management
 Effectively interfacing with people at all levels, managing healthy work
environment and inculcating bonded teamwork with high work ethics.
 Mentored, motivated and guided team members by identifying core
competencies and defining a scheduled growth plan.
Cost Reduction
Implementing strict measures in operating procedures to optimize
resource/capacity utilization
Career Highlights
TEVA API Ambernath
As a Asst Manager in Production department since Jan 2014.
Reporting to Manager-
Reported by-10 people
Notice period 3 month
-Follow cGMP & the Safety procedures and achieve Production target
given by Management .
- Working on critical reaction like Grignard and hydrogenation.
 Preparation, reviewing and implementation of Sop’s.
 Preparation and reviewing of BPR’s.
 Involved in capacity calculation , equipment selection,Utility
calculation.
 To investigate critical deviations, change control and CAPA and record
the conclusions
 Ensure quality of all products and intermediates are as per the defined
standards
 Giving training of cGMP and EHS to subordinate
 To carry out SAP related activities.
- Coordinating with R&D team to set up new process and product
- To coordinate with project department for the expansion of
manufacturing facilities, Technology Transfer department for new
product development.
- Working MS and T department and participating in continuous process verification of the
commercial process using available tools and prepare required document for the same.
- Participated in site transfer, Scale up of process from Pilot Plant/ R & D to Manufacturing
facility in close coordination with Pilot plant/R & D and Manufacturing team
- Identifdied and highlighted scale-up issues and suggest remedial measures before tech
transfer
-

Medichem Lifescience Ltd.,Tarapur Jan” 11-Jan14

Production manager
Reporting to GM- Operations-
Reported by-2 asst. Managers-
Total team -40.
Notice period 1 month

(Company Mfg. API and Intermediate)

- Follow cGMP & the Safety procedures and achieve Production target
given by Management .
- Achieved 23KL capacity installation, Filtration system like, Sparkler ,
Neutch and Centrifuge installation , Drying equipment installation.
- Installation Non-IBR boiler, Chilling plant and various centrifugal
pumps.
- Follow cGMP & the Safety procedures
 Preparation, reviewing and implementation of Sop’s.
 Preparation and reviewing of BPR’s.
 To investigate critical deviations and record the conclusions
 Ensure quality of all products and intermediates are as per the defined
standards
 Preparation of daily and monthly production reports
- Coordinating with R&D team to set up new process and product
- To coordinate with project department for the expansion of
manufacturing facilities, Technology Transfer department for new
product development.

Emcure Pharmaceutical Limited, Kurkumbh

Oct 10” -Jan 11
- Worked in Shift and monitor all production activities
- Follow cGMP & the Safety procedures
- To investigate critical deviations and record the conclusions
- Coordinating with R&D team to set up new process and product

Arch Pharmalabs Limited. ,Tarapur June” 04-Oct “ 10

- Reported to- GM works & he reported to
- Reported by- shifts –in-charge 1 executive in G shift for documentation
& coordination
- Total team – 45
- Follow cGMP & the Safety procedures
 Preparation, reviewing and implementation of Sop’s.
 Preparation and reviewing of BPR’s.
 To investigate critical deviations and record the conclusions
 Ensure quality of all products and intermediates are as per the defined
standards
 Preparation of daily and monthly production reports
- Involving in Process validation and cleaning validation
- Coordinating with R&D team to set up new process and product
- Working on ERP Module.
- Preparation of User Requirement specification
- Preparation Document like FAT,IQ,OQ,PQ and OQ
- Faced various regulatory and customer audit.
- Achieved 13KL capacity installation, Filtration system like, Sparkler,
Neutch and Centrifuge installation, Drying equipment installation.
- Installation Non-IBR boiler, Chilling plant and various centrifugal
pumps.
-
Weikfiekd Pvt.Ltd.,Pune Nov” 03-May’ 04
(Mfg. food products.)
Responsibility of production of Sodium aluminium sulphate that involves
- Worked as production officer and responsible for the sodium aluminium
sulphate
- Worked in team for developing the process.
- Responsible for production planning
- Handled manpower.
- Attended internal & external audits related to the department.
-
KDL Biotech Ltd,Khopoli Nov.’ 99-March”02

Joined as a trainee engineer and completed various assignments in

Process engineering and project engineering.
- Follow cGMP & the Safety procedures

Academia
 B.E.Chemical engineering With first class T.K.I.E.T.Warnanagar 99

Personal Details

Date of Birth : 28th August 1976

Marital Status : Married
Present CTC : Rs. 1162000