Formulation Pharma
Resume:
ARUN SARAVANAN BALAKRISHNAN
** ********* **, *********, **-08540
EMAIL ID: adp0f6@r.postjobfree.com, MOBILE: 762-***-****
VISA STATUS: H1B (I140 APPROVED)
19+ years of technical experience in the Research and Development, Technology Transfer and Manufacturing in various leading pharmaceutical companies in US & India like
Cipla, Orchid Health Care, Apotex Research, Par Formulations and API Pharma Tech.
Presently seeking a challenging position that utilizes my technical and innovative skills while providing career advancing opportunities with effective utilization benefiting the organization.
key skills
Drug Substance and Drug Product Characterisation
Formulate and Design Drug Products
Process Development, POC report, DOE, QbD and Risk Assessment
Pharmaceutical Formulation Process Development
Pharmaceutical Formulation Process Validation
Instrument Qualification – IQ, OQ and PQ
Equipment Qualification – URS, FAT, IQ, OQ and PQ
Document preparation such as
SOP’s
Specifications
Test Procedures
Development Report
Technology Transfer Report
Design and Development of Stability Programme of the Drug Substance, Intermediates and Dosage Forms.
Material Compatibility, Cleaning Validation, Filter study, Dissolution, Disintegration, Specification finalization of Drug Product.
Preparation of Drug Product for BE Study
Assisting in the ANDA filing of Drug Product for In-House or Contract Manufacturers.
Technology Transfer of R&D developed drug products to Manufacturing site.
Achievements
Execution of more than 25 exhibit Batches at Cipla Ltd, Orchid Healthcare & Par Formulations Private Limited.
Commercial Launch of around 5 products at Cipla Ltd, Orchid Healthcare & Par Formulations Private Limited
Successful completion of various Regulatory Audits during my tenure at Cipla Ltd, Orchid Healthcare & Apotex Research.
Successful Completion of the USFDA Audit at Par Formulations Private Limited.
Successful Completion of PICS Audit at Sai Mirra Innopharm Private Limited.
Successful Completion of Oral and Parenteral Dosage forms at API Pharma Tech.
Responsibilities:
Ability to remain focussed on the Formulation objectives in rapidly changing circumstances to meet the market and regulatory requirements.
Design and execute for prototype Pilot Batch and Formulations.
Planning and Execution of Pilot / Exhibit and ANDA batch Formulations of various dosage forms such as Oral dosage forms, Injectables, Spray Drying and Lyophilization Formulations as per requirements.
Pharmaceutical Formulation development and validation and assisting in Pilot process development and Clinical Batches.
Characterize the materials in physical testing of API’s and Excipients.
Training of operators and Formulation Chemists for handling of different equipment’s, systems, and process.
Perform data reviews, prepare reports and Quality Documents.
Excellent troubleshooting skills and ability to solve complex technical issues.
Compliance to laid standards of the current good manufacturing practices in Formulation.
To ensure effective implementation of quality management system as per cGMP and international requirement at all levels of Formulations.
Preparation of Chemistry, Manufacturing and Controls (CMC) and Common Technical Document (CTD) for Pharmaceutical Regulatory filings as well as cGMP related documents.
Interact with various teams and external parties involved in formulation and development and manufacturing to ensure timely completion of new product development projects.
Interact with manufacturing, analytical research, validation and supply chain to ensure smooth technology and scale-up of formulations to commercial scale.
Monitoring of capacity and manpower utilization in the Formulation Development and Documentation involved due course of Formulations.
Experience in writing technical documents, SOP’s and summary of studies using QbD principles and methodologies.
Installation, Operation & Qualification of new equipments & Area in the Formulation Department.
Possesses strong leadership, problem-solving, interpersonal and communication skills with positive attitude and willingness to work hard to achieve the Goals.
Strong Project management and Organizational skills.
Knowledge on calibration of instruments, equipments and preventive maintenance procedures. Ensure that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations
Working knowledge of cGMPs, CFR (210/211/ 820/4), ICH and applicable international regulations/guidelines.
Collaborates with the management and supervisory personnel from Operations, Quality control and Quality Assurance to resolve the problems affecting the quality and system, collaboration includes reacting, investigating and following up with Operations for non-conformance issues and a working jointly towards resolution.
Initiate investigations, CAPA and Change Control.
PROFESSIONAL EXPERIENCE
Work Experience Highlights
Excellent exposure in the Formulation of Tablets, Capsules, Liquid orals, Dry Syrups, Powder for Oral Suspension, Powder for Oral Solution, Powders, Spray Drying and Parenteral Formulations for US and Europe markets using computer aided machines having data control systems.
Responsibilities range from day-to-day monitoring of Formulation activities to documentation.
Responsibilities encompass product formulation development followed by the packing activities like container packing, Blister /Bulk packing for their stability studies, manpower handling, execution of exhibit, bio-batches for submission to the regulatory authorities and Co-ordination with other related departments.
Role in qualification of equipments like Capsule filling, Tablet compression, Liquid Filling Machines, Rapid Mixer Granulator, Octagonal Blender, FBD, FBP, Auto-Coater, Lyophilizer, Spray Drier, Blister and Bulk packing.
Operation, Maintenance and Troubleshooting of all the process instruments and equipments for continuous processing of development batches in Formulations.
Documentation including Master Production Records, Validation, Standard Operating and Cleaning Procedures, Calibrations, Area Cleaning, Equipment Cleaning and Raw Material Intending and Finished Goods Transfer etc., pertaining to the Formulation.
Documentation of BMR’s, BPR’s, Check list, SOP’s etc.,
Instrument and Equipment’s Knowledge include
Automatic Capsule Filling Machine - AF 40T and 90T
Compression Machine – CADMACH, SEJONG
Liquid Filling Machines – Volumetric Filling Machines and ROTOFILL FS-120 Liquid Fillers
Bulk Packing Line – COUNTEC-DMC-120s
COUNTEC-DMC-60s
CVC Bottle Packing Line
Fluid Bed Equipment -125L & 250L –PAM-GLATT
Power Packing Machine - Pakona
Successfully faced audits (i.e.) USFDA, TGA, MHRA, WHO-GMP and Customers audit like IVAX, WATSON, PHARMA SCIENCE AND RHOXAL PHARMA.
Educational Qualifications
2003 – May 2007 ~ Annamalai University
Master of Business Administration (MBA)
Specialization: Production Planning Control and Maintenance, Hospital Management and Quality Management
Aug 2000 – Nov 2001 ~ Institute of Pharmaceutical Technology ~ Annamalai University
Master of Pharmacy (M. Pharm)
Specialization: Industrial Pharmacy
Nov 1995 –Nov 1999 ~ Institute of Pharmaceutical Technology ~Annamalai University
Bachelor of Pharmacy (B. Pharm)
PERSONAL INFORMATION
Date of Birth: 19th August 1977
Language: English & Tamil
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