Summary :
Assignments to head SBU Operations in the areas of Operations / Production of Injectables (Liq/Lyo), Human Insulin Biological bulk Sera, Vaccines, Toxoid ,Tablet, Capsules, Liq-Orals ,TDDS & Ext. preparations Manufacturing / Project Management / Product Development with an organization of high repute.
Executive Summary :
Results driven senior management executive with multi faceted experience of around 24 years in Pharmaceutical industry.
1 Dynamic change agent skilled in repositioning organizations to achieve operational / manufacturing excellence.
2 Presently associated with FDC Ltd. Aurangabad as Production Manager
3 Experience in production, process, Tech-transfer, product development, process optimization & control, standardizing production norms & green field projects practices involving extensive use of modern instruments.
4 Competent in manufacturing & packing of various Antibiotics, Antifungal, Anesthetic Sera, Immunizing agents Anticloting vaccines, toxoid, Proteins, Blood products & Plasma derivatives in Liquid /Lyophilized Injectables dosage forms.
5 Competent in Manufacturing of Anti sera Plasma Pheresis ,plasma processing, Tetanus toxoid non culture zone ,T.T.,DPT filling & centralized packing area.
6 Competent in manufacturing & packing of various multivitamins Antibiotics, Vitamins, ant diarrheal antacid preparations in Tablets & Capsules, dosage forms.
7 Competent in manufacturing & packing of various Antibiotics, Antifungal, keratolytic preparations in Liq-Orals ,Ointments, Creams, Lotions Liniments, Powders & Shampoos Dosage Forms
8 Competent in manufacturing and packing of various TDDS dosage forms.
9 Experience in handling of Contract manufacturing tablets, Capsules & Injectables dosage forms
10 Key member of Energy conservation & cost reduction committee.
11 Key member of Validation/Calibration & Self Inspection team.
12 Proficient in validations, qualifications, maintenance, calibration and troubleshooting of various PLC based semi auto & automatic equipments & machines of Manufacturing area, thereby enhancing productivity & quality.
13 Well versed with cGMP concept defined by Schedule M, WHO, TGA, MHRA, MCA, & USFDA.
14 Ensured compliance of various quality measures such as cGLP, cGMP, Gampa by maintenance of appropriate requisite documentation/ records & training of personnel’s.
15 Delivered dramatic breakthrough improvements towards operational excellence by leading organizations to adopt business processes improvement techniques.
16 Excellent operational/analytical, troubleshooting and inter-personal skills with proven ability in driving numerous quality enhancement, process improvement and cost savings initiatives during the career span.
17 Experience in FDA , factory Licenses, & Safety rules regulations.
18 Well versed with Environmental Control & ETP operations.
19 Register Pharmacist of “MAHARASHTRA STATE PHARMACY CONCIL” ( Registration No. 33214/2016)
Education :
1. M.M.S from Pune University in 1995.
2. D.B.M from Pune University in 1994.
3. B.Pharm from Pune College of Pharmacy in 1989.
Approved By FDA :
1. Capsule Manufacturing
2. Injection
3. External Preparation
Core Competencies :
Operations & Production Management :
1. Heading Warehouse, production operations with a view to ensure timely accomplishment of production targets within the time and cost parameters.
2. Determining the future needs and production capacity for producing required quantities of items on pre-defined standards and within financial costs.
3. Planning & implementing the preventive & predictive maintenance schedules for improving the overall reliability and safety of plant equipments.
Quality Assurance/ Regulatory Testing and Inspection :
4 Ensuring stringent adherence to quality standards, norms & practices, identifying gaps, trouble shootings and taking corrective action.
5 Handling of non compliance as per CAPA quality assurance system.
6 Ensuring compliance of various quality measures such as cGLP/cGMP/GAMP thro GEP by maintenance of appropriate requisite documentation/ records.
7 Working in close coordination in work groups & supporting departments for conducting process audits and detailing on quality requirements and finalizing the quality plan.
8 Facilitating in developing experimental & pre formulation studies of drugs and other chemicals; conducting Vendor Audits &Team member of external audits of Contract manufacturing facilities.
9 Preparation of documents, required for audit preparation for W.H.O., TGA, USFDA, MHRA,INVIMA Colombia & various MOH audits (MOH Sudan, MOH, Ghana, MOH Egypt) Hospira USA. & ISO 9002
10 Key member of PPC to fulfil the market requirements.
11 Knowledge of various regulatory guidelines & contribution in quality systems as per revised guidelines in documents preparations.
12 Work as per quality systems with strict adherence of quality documents(SOP/BMR/BPR)
Process Improvement Initiatives :
1. Identifying areas of improvement and recommending process modifications and equipment calibrations, validation to enhance operational efficiencies of machine / equipment.
2. Supervising resource planning for optimizing man & machine utilization.
3. Close control & inspection of each critical operation of manufacturing products.
People Development :
1. Setting direction, energizing, mentoring, coaching, motivating, guiding and supporting teams.
2. Developing, managing and monitoring the performance of multi-skilled large work force and conceptualizing need-based training programs for performing maintenance operations.
3. Delegating work schedules for smooth functioning of operations & leading people working at all level in an organization.
4. Training needs identification & evaluation of personnel training with the help of Training matrix.
5. Empowering & motivating subordinates to achieve the organization goal.
Organizational Experience :
At present working in FDC Ltd. Aurangabad as Manager Production Since Nov. 2012
Company having USFDA,MHRA,MCA/ISO9002& other RWTC accredation for export
Role in FDC Ltd. :
Planning of all production activity in plant for Ophthalmic, Powder and liquid dept.
Responsible for delivering goods in time for all export batches (Export to UK/US/ semi regulated markets.)
Responsible for handling of all regulatory audits like MHRA /USFDA/various customers audits, etc.
Responsible for all production related activity likes ordering of all Production equipment, water system, stage wise inspections, installation, qualification and execution of production activity.
Well experienced in Documentation of all activity including preparation of SOPs, BMRs, BPRs, Validation Protocol, etc.
Well experienced in handling all Production related decisions.
Maintaining the performance of each Production Associate and subordinate.
Well experienced in Planning of Monthly, weekly and daily production activity and organizing requirement accordingly.
Responsible for coordinating with other department like Quality control, R & D, Engineering, Stores, purchase, etc.
Responsible for Manpower management and training of them for different activity.
To check the record of S.O.P., cGMP and safety procedure.
To check the batch wise yield achieved for each product and compare the same with standard yields.
To carryout the validation of equipment and Area and record the same.
Training & evaluation of shop floor personnel as regards of Machine operation, cGMP, Quality system, Documentation, etc.
Sidmak India Ltd. Since Nov’08 Oct. 2012 :
G.M.Production/Warehouse/Purchase/Engineering Dehradun Uttrakhand Reporting to Director-Technical at USA
USFDA approved facility.
Role :
Overseeing the entire operations of the Tablets, Capsules, & production of Tablets, capsules, Bottle filling of bulk pack labeling/packing & Water system including Warehouse, Production, Maintenance & Projects Department.
Leading a team of 80 personnel’s through a team of Manager 04 & 3 Asst. Manager Production/packaging /Maintenance/ Project Ware house/Purchase & coordination with F&D ,Purchase, Regulatory & Marketing
Bharat Serums & Vaccines Ltd. Jun’06 to Oct’08
The company having WHO, MOH SUDAN, Ukraine,EGYPT, GHANA,NIGERIA, INVIMA Colombia .
Deputy General Manager -Manufacturing-Injectable Unit
Role :
Overseeing the entire production operations of the Inject able Unit; including production, water system , Labeling/Packaging lines, Stores & Maintenance.
Leading a team of 70 personnel’s through a team of Manager production,03 Asst. Manager production/packaging /Stores , 3 executives 10 Production Officers of water system, Packing & Production, Stores , Maintenance & coordination with Q.C. ,Q.A. Planning, FGS Development cell ,R&D & Regulatory
Faced the audits of TGA, MOH Egypt, MOH Sudan, MOH Ukraine , MOH Ghana, Baxter, INVIMA Colombia & HOSPIRA USA audits.
Ensuring fulfillment of all the requirements of Schedule M of Drugs and Cosmetics Act.
Handling installation & commencing of Freeze Dryers; qualification & validation of Freeze Dryers.
Handling of Market complaints as per procedure.
Training needs identification & evaluation of personnel training with the help of Training matrix.
Preparation of budgets, WIP, APR & annual production plan & reports.
Looking after Cyclosporine oral solution facility projects.
Active participation , experience in INVIMA Colombia audits from 12/05/08 to 16/05/08 & got certification for products manufactured in Line 1,2 & 3
Experience in Lyophilizer validation different product cycle setting
Experience in QA functions like SOP preparation, Validation documents, VMP, SMF, Quality policy, TT policy, raining policy.
Participated in Cleaning validation, Area validation, Qualification, Validation, APR preparation MPCR preparation, Preparation of various val idation protocols including process validations, Self inspection & various quality audits.
Quality system documents preparation & training to subordinates like CCP, OSS, deviations, Validations etc.
Highlights :
Performed FAT of Lyo-Filling & Sealing Line in Groninger at Germany.
Participated in a 2 days seminar on Freeze Dryer at Hotel Leela by Biopharma U.K
Participated 2 days seminar on EU/USFDA inspection requirements in Hotel Regency at Mumbai.
Project :
Adept at planning & execution of projects for plant set up, plant expansion, modernization and installation / commissioning of equipments.
Projects handled-
1.
AT RALLIES INDIA LTD. – SVP WHO products
2. AT CIPLA LTD. – a) Goa Liquid/Lyophilized injectables & Dry powder for USFDA products.
3. AT BHARAT SERUMS & VACCINES LTD. –Cyclosporine Liq-Orals.
Knowledge Purview :
Installation, qualification/validation & operation of PC & PLC based Freeze Driers e.g. Terruzzi, TLC 150 CS, VIRTIS Ultra 35 Martin Christ 65DS & 160DS.
Installation & Operation of Ultra filtration, ROEDI & Multieffect still (PSG+WFI) of Christ Nishotech & Aqua nova.
Installation, Validation & operation of Vial Washing Filling/Sealing Groninger Line.
Installation, Validation & operation of Fedegari Steam Sterilizer cum Bung Processor
Procurements of equipments m/c preparation of qualification records & reviewing of validation documents for new facilities.
Installation, Validation of Optimize Transdermal M/C for patches.
Setting, qualification, operation of various M/C from conceptual drawing to commercial batch production.
Process optimization & validation in PASK I.V product in Tefflon make Lyophilizer.
Installation, validation & operation of LSI make lyophilizer.
Installation, validation & operation of 52 st. Camack Compression M/C
Installation, Validation & operation of Auto coater 60” PAM GlLATT
Installation, qualification & operation of Extruder of Japan make
Installation ,qualification & operation of Fully automatic bottle washing to induction sealing m/c of Countec make of Germany.
Installation, Validation & operation of 45 st. Cadmak compression M/C.
Installation ,qualification / validation & operation of various M/C/Equipments in Granulation area including VTS.(RMG, FBD, Paste kettle, Conta/V blender 10Cu. Ft & 20Cu. Ft.)
Temperature mapping of area suit the environmental monitoring requirements.
Handling of BMS system for environmental monitoring & controls.
Process validation & ANDA batches of various products.
Attained training on 21 CFR cGMP External training by Mr. Atul Shirgawkar Technical consultant. (5 days 20-12-2010 to 24-12-2010)
Attained External training of 21 CFR USFDA on six systems of USFDA audits delivered by Dr. Bauokhandi as Technical consultant of GMP Pharma. Inst. Pvt. Ltd from Jan.2011 to Aug. 2011)
M/s Cipla Ltd., Goa Unit V & IX :
Production Head Injectable Unit
Sep’04 to May’06
The company having WHO, USFDA, MHRA, & TGA Approvals.
Role :
Managing a gamut of activities
From March 2004 :
Working as Production Head at Cipla Goa M/s Oncocare Unit No. V
1 Made the production related documents and faced the USFDA audit.
2 Documents related to USFDA UNICEF MHRA,MCA TGA &various MOH Audits
3 Working with team of 28 production (Management and Operating) staff to achieve the monthly production schedule and achieving the production target.
4 Planning of the production schedule. Coordinating with planning, Export department for completing the production targets.
5 Review and updation of all the production documents to meet the current cGMP requirements or based on GMP Trends and regulatory inspection compliance.
6 Preparations of Batch manufacturing records, SOPs, Qualification documents.
7 Completed the installation of the Imported complete vial line (Washer, Dehydrogenating Tunnel, filling & sealing machine) from M/s Groninger GmbH. And also knows the operating knowledge.
8 Done the startup validation of the area and the equipments.
Worked on : M/s Klenzaids filling line knows the operation and maintenance knowledge of Multicolumn distilled water plant, Pure Steam generator, SEPTRON Purified water generation system from M/S Christ Germany (1000 LPH). Knows the operating knowledge of the Freeze Dryer from M/s Christ Germany having 65 Kg ice condensing capacity.
Freeze Dryer
1 Preparation of URS & forwarding to different suppliers
2 Comparison of FDS received from Suppliers.
3 Selection of Lyophilizer with techno commercial comparison
4 Reviewing of FAT protocols of Supplier as per cGMP
5 Installation & qualification of Freeze dryers
6 Involved in validation of Lyophilizer CIP,SIP,Cycle development
7 Development of Lyophilization cycle in consultation with R&D
8 Training of subordinates on Lyophilization operation & maintenance
9 Media filling, process validation & commercial production in lyophilizer
10 Revalidation of lyophilizer as per schedule
Contract Manufacturing :
1. Preparation of quarterly rolling plan in consultation with Material & marketing Department.
2. Schedules for the RM/PM
3. Release of RM/PM
4. EOQ of Excipients/less value items
5. Preparation of production planning
6. Monitoring of Manufacturing/packing & dispatches of products n time in coordination with contract manufacturing units to marketing.
Duties & Responsibility :
Monitoring and controlling the production activity, co-ordination with planning & export coordination department fulfilling the export and local market requirement . Audit preparation and compliance of the audit points. Training to the staff. Manpower management . New product development trial with the help of R & D
Heading the department.
Facility projects for Liquid/Lyophilized products & Dry syrup at Unit IX active involvement from conceptual drawing to commercial batch production.
Highlights :
1 Successfully completed the ANDA registration batches of Granisetran Injection & Insulin of different strength in 2005.
2 Successfully completed the ANDA registration batches of Minocycline hydrochloride all 5 strengths, Trospium & Nitrofurantoin.
3 Successfully completed the ANDA registration batches of Acetozolamide ER capsules.
4 Handled installation of imported complete vial line (Washer, Dehydrogenating Tunnel, filling & sealing machine) from M/s Groninger GmbH.
5 Independently handled Unit IX Liquid & Lyophilized Injectable Project.
6 Products handled both Lyophilized and Liquid Inject able in Cipla at Unit V & IX.
7 Set up & preparation of OSD plant readiness for USFDA
Unit IX :
Liquid Injectables : Insulin Injection & Granisetran Injection
Lyophilized Injection : Antibiotics,Rabeprazole Injection, Azitrhomycin 500 Injection, Tecoplanin Injection 200 & 400, Omeprazole Injection
Achievements :
1. Control of weight variation in capsules with adequate in process controls.
2. Manufacturing of bulk with respect to capacity of lyophilizer to meet the cGMP requirements.
3. By strict monitoring & control reduced the ampoule breakages in terminal sterilization to improve the yield by 2% in Rallies india /Bharat serums & vaccines Ltd.
4. Cost saving in QC sample by increasing the batch sizes of products.
5 Initiator for the camp ion runs of products for adequate utilization of facilities in Shreya & Bharat serums Ltd.
6 Lyophilization cycle reduction in Shreya Life Science & Bharat Serums Ltd. by 3 hrs in Sec. Drying by increasing the temp. from 25 Deg. to 35 Deg.
7 Member of Energy Conservation in Shreya Life Sc. & Cipla Ltd.
8 Cost reduction of consumables & stationeries by closely monitoring & controlling the issues.
9 Reduced factory overheads from 25 L to 15 .0L in Sidmak Laboratories Pvt. Ltd.
10 Reduction of rejection at various stages of production &improved yield of products by 1 to1.5%
11 Reduced C/O & down time of machines & equipments by planning , interdepartmental co-ordination & maintaining critical spares of M/C & equipments as per suppliers recommendation.
12 Target production by use of available resources & 5% net saving on Capital budgets of Departments.
13 Yield improvements by carefully studying each operation as a unit operation & minimizing rejection at various stages of production.
14 Plant made US FDA compliance within 2years (Sidmak Laboratores.Pvt. Ltd. )of joining. Preparatory work includes project finishing, Ordering and installation of equipments and related documentation like URS, DQ, FAT, IQ, OQ and PQ.
15 Proposed and implemented various significant cost improvement ideas in Sidmak Labs. Ltd.
16 Technical trouble shooting in various areas to avoid the noncompliance.
17 Successful audits faced in FDC Ltd. UKMHRA / various customer audits like/Apotex Pharma/ ISO
18 Suggested the changes in facility design to minimize the movement of material
AUDITS FACED :
1. US FDA
2. MHRA
3. WHO (GENEVA)
4. WHO
5. MCC
6. TGA
7. Various audits from African/Middle east countries and Nonregulated markets.
8. Customer Audits from various countries.E.g. Baxter
9. ISO audits.
Previous Assignments :
M/S FDC Ltd. Prod. Manager Nov. 2012
M/S Sidmak Labo. Ltd. GM-Prod. Nov.08 to Oct.2012
M/S Bharat Serums & Vaccines Ltd DGM-Manufacturing Jun’ 06 to Oct’08
M/S Cipla Ltd. Goa Head Production Sept’04 to May’ 06
M/s Shreya Life Sciences Asst. Manager-Production Nov’97 to Aug’04
M/s Emcure Pharma, Pune Production Executive Dec’94 to Oct’97
M/s Serum Institute of India Ltd., Pune Production Officer Apr’91 to Nov’94
M/s Litaka Pharma, Pune Production Supervisor Jul’89 to Apr’91
Extra Curricular Activities :
1 Participated actively in Community Social Work.
2 Participated and completed The Pune International Marathon, Cross Country and other events.
3 Completed Memory development work shop for 7 days in Aurangabad & Mumbai.
4 Participated actively in 2 dyas workshop on Cross functional team discipline YMCA Mumbai.
5 Participated & completed 7 days Memory developments & meditation course at Aurangabad.
Personal Details :
Nationality : Indian
Location : Aurangabad
Expected CTC : Negotiable
Declaration :
I hereby confirm that the information furnished above is correct to the best of my knowledge.
Date : ___________
Place : ___________