SHAILESH KUMAR

Management Professional

** ***** ** ***** ********** expertise in Operation & Supply chain with Quality compliance

Ä Production Management Ä Quality Compliance ÄThird Party & Audit

A principal executive ‘point of contact’ for company accountable for ensuring that appropriate business strategies are in place and are acted upon according to the priorities.

CAREER OVERVIEW

Manufactruing - packing Quality Management System Supply chain management Project management Strategic Planning Material Management Risk Management Inventory Management Electronic documentation Regulatory Audit

Key responsibilities are directing to NATIVITA in operation and quality compliance activities, including production operations, manufacturing engineering, materials management and equipment/facilities maintenance, to ensure maximum effectiveness is obtained for the production of quality products within specified time and budgetary guidelines.

Leads the Manufacturing sits an Injectable facility including well versed of Lyophilisation activity –( MABs Monoclonal antibodies, antibody drug conjugates, proteins and vaccines.) and Oncology (Solid Dosage ) facility which is responsible to maintain and improve the scientific oversight of the manufacturing processes and technical changes, the relevant body of technical knowledge and capabilities at the Site and to ensure the products stewardship, across process units and functions at Site.

Oversee and ensure the robustness and capability of manufacturing and packaging processes by monitoring of each product’s Critical Process Parameters (CPP) and Critical Quality Attributes (CQAs) thru a continued process verification program.

CORE COMPETENCIES

CAREER SCAN

MAR 2019 - Till with NATIVITA Pharmaceutical as Head Production

Responsible for directing manufacturing operations in the production of Oncology & Parenteral formulations and manufacturing processes for various biologics modalities such as gene therapies, monoclonal antibodies, antibody drug conjugates, proteins and vaccines reporting, training, staffing, development, Compliance & Continuous Improvement.

Ensure compliance with cGMP and regulations. Proactively seeks ways to improve GMP efficiency and compliance. Formulates and directs the development and implementation of manufacturing goals, objectives, policies, products and systems.

Accountable to ensure products meet or exceed quality standards, required delivery schedules are met, and leadership is provided in continuous improvement activities to successfully enable scalability while achieving corporate goals of quality, cost, and delivery

Formulate and direct the development and implementation of goals, objectives, policies, procedures, and systems pertaining to the manufacturing operations function.

Tracks and reports manufacturing outputs on a monthly basis.

Prepares annual budget for manufacturing operations.

Directs all daily activities for entire production staff.

Conducts investigations and provides CAPA for all manufacturing related discrepancies.

Responds to regulatory agencies and third party inspections on matters related to manufacturing operations.

Provides support for all R&D and validation activities for scale-up and submission batches for regulatory agencies approval.

Responsible for the hiring and training of operators and supervisors providing effective and timely feedback to create rising expectations.

Organize and execute work assignments to meet efficiency and utilization expectations

Demonstrates Potential Problem analysis mind-set to anticipate and prevent issues resulting in losses or downtime. Shows enhanced preparation based on risk and knowledge

Identifies improvements in procedures, systems, processes, resulting in improved quality and compliance.

Leads investigations, demonstrating trouble shooting and root cause analysis to complete, enter in track wise getting approval of QA

Consistently identifies critical steps in the process, providing enhanced supervision and involvement to ensure success

PRIOR EXPERIENCE

Jan2015- Feb 2019 with LIFE PHARMA FZE, DUBAI, UAE as Production Manager

Direct reporting: Vice president.

Key Result Areas:

Handling the manufacturing & packaging of Pallets( Mumps coating, compression,) Tablets, Capsules Dry Syrup and Liquid syrup and Suspension entailing with equipment of Dry granulation, wet granulation, Direct mixing, Capsule filling, Tablet compression, Tablet Coating, Blister Packaging, Strip Packaging and Bottle(CVC & Swift) packaging of tablets and capsules with machines of different capacities and make.

Coordinating with various functions; ensuring optimum utilization of the resources and implementing & maintaining the quality management systems (QMS).

Managing master production schedule (MPS) and inventory level.

Creating new packaging design as per current and upcoming market requirements; developing detailed packaging specifications to ensure quality and cost effective materials.

Coordinating with the Planning & scheduling department to ensure essential productivity during the runs; developing plan which meet cost effective targets, are sensitive to environmental needs and protects the product throughout the distribution channel.

Conducting challenge tests to evaluate packaging material and design in compliance with product needs; attending troubleshooting in shop floor, providing technical support to the ongoing operations & sequences in manufacturing processes.

Ensuring quality product delivery; managing overall operations involved in production planning including coordinating with other department (PDL, RA, Validation, and Engineering) manpower management, supplies and up-time of equipment’s.

Supervising critical process parameter of granulation, compression and coating activities.

Overseeing production of various molecules and implementing plans with a view to ensure timely accomplishment of production targets within the cost parameters.

Facilitating process implementation of all production activities of various API as per approved facilities.

Managing quality across raw materials, work in progress, finished goods in various functional departments as per CGMP standards; handling preventive maintenance of various equipment’s to minimize downtime.

Guiding staff, monitoring the performance of team members to ensure efficiency in process operations and meeting of production targets.

Carrying out routine validations & actions to be taken if results are not within specified limits.

Planning manpower for smooth execution, reaching to quality, quantity, time & cost parameters.

Coordinating with various departments/leading teams for ensuring the accomplishment of monthly production targets along the SOP guidelines.

Accountable for strategizing, coordinating and scheduling production activities and controlling the production process on the shop floor.

Supporting for planning, organizing, directing staff control of production activities and coordinating the operation entailing planning, resource utilization & manpower management.

Actively Participation in process validation, Site transfer product development, cleaning validation and trouble shooting of OOS batches of the Product, change control, cross Functional investigation, FMEA etc. and Qualification of the Equipment and area.

Handling scaling up & enhancement of exiting process, monitoring of production practice and setting the schedules as required.

Administered the batch documentation as well as day to day documentation, ensuring compliance & adherence to quality standards.

Notable Attainments:

LIFE Pharma is the 1st Pharmaceutical unit in UAE and GCC for filling its own ANDA in 2017 and in September 2018 completed the 2nd USFDA audit successfully.

This Unit is also approved by UK-MHRA, Australia-TGA, South Africa-MCC, MOH Kenya, and NDA Uganda.

Successfully implementation of fully paperless system with compliances of 21CFR part11 (electronic records, electronic signatures, final rules).

Taken initiative in rolling out SAP-R3 Module which includes material management (MM) Breakdown orders, Preventive Maintenance Orders, Calibration module, Engg, change Management, Deviation and Incident Management etc.

Instrumental in Exhibit/Validation Batch:

Executing validation batches and resolving scale up issues in collaboration with PDL team.

Understanding the new processes and providing product specific training to the team members for validation batches.

Proficiently participated in change control and managed deviations, CAPA, investigation through track wise system.

Resourcefully addressed the Market complaint procedures through investigation and CAPA procedure.

Effectively handled External Audits (USFDA, MHRA, TGA, ANVISA, and WHO-Geneva) and other internal audit (Non-regulatory bodies).

MAY’ 2006 - JAN’2015 with Ranbaxy Labs Ltd., Dewas as Production Manager

Cephalosporin (Beta Lactam) Manufacturing Block.

Direct reporting: Plant General Manager

Job responsibilities/Profile:

Responsible for core Manufacturing area, ( From receiving of Raw material to primary packing via granulation, compression, coating )

Responsible to make monthly production plan and to meets production delivery schedules.

Scheduling production activities and controlling the manufacturing process on the shop floor.

Supporting for planning, organizing, directing staff control of production activities and coordinating the operation entailing planning, resource utilization & manpower management.

Monitoring and fixing of critical process parameter in process validation, Site transfer product development, cleaning validation and trouble shooting.

Actively handle quality management system through Track wise software like- Deviation, Change control, Risk management, Cross Functional investigation, FMEA etc. and Qualification of the Equipment and area.

Handling scaling up & enhancement of exiting process, monitoring of production practice and setting the schedules as required.

Administered the batch documentation as well as day to day documentation, ensuring compliance & adherence to quality standards.

Reviewing the approval of SOP’s related to production & packing department and its online updating through document compliance manager (DCM) system.

Learning Management System (LMS) activity used for training module of SOP, Validation Protocol.

Achievements:

Successfully initiated Lean Management system by using of 5S & KRA.

Through stabilizing of VSM, Equipment OEE increase from 36% to 56%.

Reduce the lead time of WIP batch manufacturing.

Reduce Primary packing material variance form 17% to 8%.

Increasing Batch yield of the many product through changing process flow.

Jul’2005-May’2006 with Sun Pharmaceuticals Ltd., Jammu as Sr. Production Officer

Job responsibilities/Profile

Follow production schedule and allocating technician on work place with their Job roles.

Record batch manufacturing data online and imparted on-job training to team members.

Maintained discipline in department and prepared URS for new equipment.

May’04-May’05 with Ranbaxy Labs Ltd., Ponta Sahib as Production Supervisor

Education and Language Details

M.B.A. (Human Resource) from P.T.U.

B. Pharmacy from Barkatullah University

Certified Six Sigma Black Belt.

Language:

English

Russian

Hindi

IT FORTE & Software

Track wise system software for Quality management system (QMS).

Learning Management System (LMS) software for training management

Document compliance Manager (DCM) software for document management system.

Electronic Batch records( eBR)

Electronic change management (ECM)

Conversant with MS Office and SAP.

PERSONAL DOSSIER

Date of Birth: 26th February, 1980

Marital Status: Married

Permanent Address: Ramchanderpur, Bihar Sharif Dist., Nalanda, Bihar (INDIA)

Current Address: Building 36/1 Flat-28,Chhakalwa street,Vitebsk,Belarus (Europe)

Reference:

Mr. Svetoslav dinkov

Corporate Senior Quality Auditor

Alvogen Sofia, Bulgaria

Contact no. +359-*********

Mr. Praveen Chaudhary

Sr. Vice president

FELIX PHARMACEUTICAL

INDORE, INDIA

Contact no. +91-870******.

Mr. Hemant Samadhyia

Quality Compliance Auditor

Dubai. UAE

Abbott Laboratories S.A Contact No. +971-*********

“Head of Operation” NATIVITA

Bachelor of Pharmacy (B.Pharma)

Master in Business Administrator (MBA)

“Certified Six Sigma Black Belt”

Vitebsk, Belarus (Europe)

Mobile: +375-*********, +375-********* E-Mail: adfrof@r.postjobfree.com

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