Quote Of The Month
"Innovation distinguishes between a leader and a follower"
-Steve Jobs
OUR EXPERTISE HERE AT MANOJ CREATIONS 0007
Explore and Avail Services
Enterprising professional with of proven expertise in Site Management & Operations, Process Operational Excellence and Project related Operations
Proven skills to enhance the Factory, Site Manufacturing Operations
Spearheaded operations encompassing project management, third party operations, audits, resource optimization & capacity utilization
Managed end-to-end facility from designing, installation to commissioning aspects in latest machinery technologies
Expertise in Greenfield and Brownfield project management; managed several projects at different organizations and executed the same
Successfully managed and drove FDA audits while ensuring all time regulatory readiness &compliances for Schedule-M, PICS, WHO, MHRA, USFDA, ANVISA, MCC, and EU GMP guidelines
In-depth knowledge of PICS/FDA related matters, GMP Audits and WHO-GMP documentation
Proactively assisted in enhancing plants Kaizens, operational excellence and profitability through the early detection of productivity deficits
Implemented quality systems like Batch Deviation, Change Control, CAPA, OOS, OOT, Market Complaint for the external clients
Proven capabilities to enhance production process operations, optimize resource & capacity utilization, escalate operational efficiencies while curtailing costs & expenses
Excellent in , designing solutions; strong customer-centric approach, motivated to deliver quality results
Track record of spearheading service improvement programs for minimizing gaps in productivity and effectiveness in service delivery
Notable success in leading design, development and delivery of complex projects and high complex solutions
GREENFIELD PHARMA PROJECT
M/s. Immacule Lifesciences Pvt. Ltd. , Nalagarh , Himachal Pradesh (INDIA)
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PROFESSIONAL EXPERIENCE
Background & Expertise
SITE HEAD & VICE PRESIDENT OPERATIONS & PROJECT MANAGEMENT - M/S. CADILA PHARMACEUTICALS LTD. - UDAIPUR , JAMMU
February 2023 - Till Date
Responsible for the handling of the entire Project site current status related to Excavation, Erection, Cvil Constructions in line with the cGMP based US Markets regulatory Operation for Injectable Lyophilised Products . Project planning related to Area Layouts, Machine Designs, Other Expansion projects in Dry Powder Injectables, Liquid Injectables, etc. Planning of Quality, R&D, PPIC, Purchase, Manufacturing, Engineering, Warehousing, Excise, Projects for this new site and further execution of batch productions and validation activities within stipulated timelines; Creating GMP work Culture & direction to site manufacturing personnel and defining priorities.
Further Handling of the OSD, Softgel, Hospital Supply cGMP Site at Jammu for Operation - Quality, PPIC, Purchase, Manufacturing, Engineering, Warehousing, Projects for the operational site and execution of batch productions and validation activities within stipulated timelines; Creating GMP work Culture & direction to site manufacturing personnel and defining priorities.Heading, site effective resource planning for optimising utilisation, reducing wastes for enhancing productivity.
Reviewing and approving the SOPs, Protocols and Reports related to QC, QA, maintenance, warehousing and Production.
Delivering the training for various cGMP topics for technical staff at site for SOP and on job training.
Monitoring quality/production procedures of products manufactured at the external manufacturing sites
Benchmarking with global best practices and implementing the same in the organisation by Defining quality standards for each operation in the organisation.
Conceptualising and implementing effective techniques to attain operational efficiency, improving quality standards and generating maximum cost savings.
Generating effective procedures for preparation and implementation of programs within all areas of safety, health and environment in manufacturing process by Modulating the knowledge level for ETP Management, Govt. Liasoning, Waste Management, PPE Management, etc.
Leading and managing cross-functional teams to ensure effective collaboration and timely execution of project milestones.
Developing and implementing risk management strategies to identify and mitigate potential project risks.
Ensuring compliance with all regulatory and legal requirements for manufacturing, storage and distribution of pharmaceutical products.
Establishing and maintaining relationships with key stakeholders, including suppliers, regulatory authorities and industry associations.
Conducting regular audits of the manufacturing processes to identify areas for improvement and ensure adherence to quality standards.
SITE HEAD & VICE PRESIDENT : OPERATIONS & TECHNICAL SERVICES. - M.J.BIOPHARM. PVT. LTD., TALOJA,NAVI MUMBAI
July 2019 - June 2021
Handling the entire GMP / PICS / Russia / Emerging / Domestic Markets Operation site planning for Quality, R&D, PPIC, Purchase, Manufacturing, Engineering, Warehousing, Excise, Projects and execution of batch productions and validation activities within stipulated timelines; Creating GMP work Culture & direction to site manufacturing personnel and defining priorities
Managing the third party, Country, Regulatory audit needs of vendors to qualify and follow-up for the audit compliances
Heading, site effective resource planning for optimizing utilization, reducing wastes for enhancing productivity.
Guiding the FND team on various Projects related to Bio Pharmaceuticals.
Reviewing and approving the SOPs, Protocols and Reports related to QC, QA, maintenance, warehousing and Production
Delivering the training for various cGMP topics for technical staff at site for SOP and on job training
Monitoring quality/production procedures of products manufactured at the external manufacturing sites
Benchmarking with global best practices and implementing the same in the organization by Defining quality standards for each operation in the organization,
Conceptualizing and implementing effective techniques to attain operational efficiency, improving quality standards and generating maximum cost savings
Generating effective procedures for preparation and implementation of programs within all areas of safety, health and environment in manufacturing process by Modulating the knowledge level for ETP Management, Govt. Liasoning, Waste Management, PPE Management, etc.
SITE HEAD & VICE PRESIDENT – OPERATIONS
( CONSULTANT - USFDA) - M/S. STERIL GENE LIFE SCIENCES PVT. LTD., PONDICHERRY
January 2019 - June 2019
Directing the entire GMP / USFDA Operation site planning for Manufacturing, Engineering, Warehousing, Projects and execution of batch productions and validation activities within stipulated timelines; providing work direction to site manufacturing personnel and defining priorities
Spearheading the supervision and implementation of cGMP in manufacturing area, delivering training on revised SOPs, monitoring critical process parameters and operational safety
Leading effective resource planning for optimizing utilization, reducing wastes for enhancing productivity
Reviewing and approving the SOPs, protocols and reports related to QC, QA, maintenance, warehousing and production
Managing the third party, Country, Regulatory audit needs of vendors to qualify and follow-up for the audit compliances
Delivering the training for various cGMP topics for technical staff at LL site for SOP and on job training
Monitoring quality/production procedures of products manufactured at the external manufacturing sites
Defining quality standards for each operation in the organization, benchmarking with global best practices and implementing the same in the organization
Conceptualizing and implementing effective techniques to attain operational efficiency, improving quality standards and generating maximum cost savings
Conducting failure investigation analysis to identify gaps and implementing corrective measures
Generating effective procedures for preparation and implementation of programs within all areas of safety, health and environment in manufacturing process
PLANT HEAD-OPERATIONS & ASSOCIATE DIRECTOR - DR. REDDY'S LABORATORIES PVT. LTD , BADDI
July 2015 - December 2018
Establishing FND /TST – new molecules trial / pilot batches; drove internal facility audits
Led the commissioning of facility, party account settlements, new material finalizations, vendor audits
Spearheaded the installation of new project at the site level; successfullyexecuted validations
Administered developments at pilot scale, steered facility commercialization with fully automated isolator based filling/sealing line, robotic product transfer based ointment/creams/injectable packing lines, higher capacity auto transfer granulation suites, automatic latest compression & coating modules, fully integrated warehousing concepts
EDUCATIONAL CERTIFICATION FLAGS
My Studies
1989 - 1993
BACHELOR IN PHARMACY(GCP)
GOA COLLEGE OF PHARMACYÂ
GOAÂ UNIVERSITY , TALIGAON , PANJIM , GOA
November 2008 - June 2021
CGMP TRAIN THE TRAINER COURSE ,
CGMP AUDITORS QUALIFICATION COURSE ,
ISO 9001:2015 QUALITY MANAGEMENT SYSTEMS LEAD AUDITOR COURSE ,
CERTIFICATE COURSE IN DRA
INSIGHT SYSTEMS INC. PUNE , MAHARASHTRA
UDEMY INC.
May 2006 - October 2021
GEMBA KAIZEN,
STRATEGIC LEAN INTEGRATED MANUFACTURING CONCEPT ,
SIX-SIGMA BLACK BELT
KAIZEN INSTITUTE , PUNE , MAHARASHTRA
INDIAN STATISTICAL INSTITUTE , PUNE , MAHARASHTRA
July 2021 to June 2023
MBA - MASTER IN BUSINESS ADMINISTRATION
(OPERATIONS MANAGEMENT)
NMIMS , MUMBAI , MAHARASHTRA
SKILLS
Professional Competencies
TRAINING
Individual Development & Upliftment Programme
cGMP & Global Regulatory Perspective Programs
Individual Development (Personality)
Kaizen & Six-Sigma Concept
School / College themes
Safety Alerts
LEAN Manufacturing Modules
Commercial Workout Patterns
Operational Excellence Modules
Industrial Budgeting Modules
Cost Saving Measures Workouts
CGMP AUDITS & COMPLIANCES
AUDITS PARTICIPATION / HANDLING SCENARIO
Roles & Responsibilities
1995 TO 1995 – FDA
1995 TO 2001 – FDA,TGA
2002 TO 2005 – FDA , USFDA
2005 TO 2006 – FDA , MHRA
2006 TO 2011 – FDA, WHO
2011 TO 2013 – FDA, WHO, TP, ANVISA
2013 TO 2015 – FDA, ANVISA, UKRAINE
2015 TO 2018 – FDA, UKRAINE, EUGMP(ROMANIA), RUSSIA
2019 TO 2019 – FDA,TP, JAPAN, UKRAINE, USFDA,EUGMP(HUNGARY).
2019 TILL DATE – FDA, TP, SAHPHRA, EUGMP(HUNGARY), RUSSIA
LET’S CONNECT
BF4Â , First Floor , Bwing ,Sukhsagar Appartment Co-Operative Housing Society LTD,
Sainagar ,
Ponda , Goa
403401
+91 8699830866