BIO DATANAME:Kiran Prabhakar Deshmukh.DATE OF BIRTH:25TH NOV 1971EMAIL ID:deshmukh_kiran@rediffmail.com, PASSPORT NO:A-2537949EDUCATIONAL QUALIFICATION:Bachelor of pharmacy (B. Pharm) 62% first class, Pune University.APPROVAL:Approved in injection manufacturing FDA Govt.of Maharashtra. Approved in vaccine filling by FDA Govt. of Maharashtra.PRESENT ORGANIZATION: Presently working with Meiji Pharma Japanese multinational at Hyderabad as Senior General Manager sterile injection production. (Site operation head)JOB RESPONSIBILITIES INCLUDESCommercial production for ROW & EUROPE market.Planning, executing & achieving production targets, optimum utilization of resources.Compliance to the regulatory requirement.To face the regulatory audits.Preparation of MIS report, Budget preparation.Operation Excellence.Achieving the KPI.Production & Productivity increase.Cost control.Audit compliance.Gap analysis.Carrying out investigation & risk assessment.Overall responsibility of Plant operation.

EXPERIENCE: Worked with Wockhardt limited, Biotech Park, Aurangabad as Assistant General Manager in Formulation Department from July-2005 till June-16.JOB RESPONSIBILITIES INCLUDES1.Responsible for 02 formulation departments which includes 04 lines viz-vial, cartridge, PFS & Combi line for Ophthalmic/vial.

2.Commercial production for Row, UK and USA market.

3.Planning, executing & achieving production targets, optimum utilization of resources.

4.Handling of manpower

5.Co-ordination with QC, PPC, Stores, Maintenance, for production activity.

6.Documentation

7.Training of manpower for various function of formulation department.

8.Looking after overall production activities such as filling, sterilization, inspection and packing.

9.Responsible for overall good manufacturing practices in dept.

10.Planning and execution of validation activity.

11.Installation of new equipment and its qualification.

12.Preparation and updation of the standard operating procedure.

13.Filing of GMP documents such as change controls and deviations.

14.Carrying out investigations & risk assessment.

15.Planning and execution of batches for US and UK filing.

16.Compliance to the regulatory requirement.

To face the regulatory audits.Preparation of MIS report, budget preparation.Operation excellence.Achieving the KPI.Production & productivity increase.Cost control.Audit compliance.Responsible for the Pharma & Biosimilar (Insulin & analogues, Erythropoietin) formulation mfg/Pkg section. (Vials, Opthalmics, PFS & Cartridges.)

AUDIT FACED: USFDA, MHRA, WHO, ROW-ANVISA BRAZIL, MEXICO, PEERU, GULF.ACHIVEMENTS:

1.Successfully faced USFDA and MHRA audits.

2.Increase in production and productivity.

3.Development and execution of documents as per regulatory requirement.

4.Completed around 100 nos exhibit batches for UK and USA market successfully.

5.Implemented systems as per the regulatory requirement.

6.Reduced overall cog/ unit.

7.Cost reduction in products & process.

EXPERIENCE:From Feb 2003 working with m/s. Serum Institute of India Ltd.Pune as Production Executive in Viral Vaccine filling dept.JOB RESPONSIBILITIES INCLUDES

1.Filling of lyophilized viral vaccines.

2.Planning, executing & achieving production targets, optimum utilization of resources.

3.Handling of manpower.

4.Co-ordination with QC, PPC, Stores, Maintenance, for filling of viral vaccine.

5.Documentation.

6.Training of manpower for various function of viral vaccine filling.

7.Looking after overall production activities such as filling, sterilization, and inspection.

8.Responsible for overall good manufacturing practices in dept.

9.Validation of equipment like DHS, Autoclave according to load patterns.

10.Validation of tunnel.

11.AHU validation.

12.Area validation.

13.Environment monitoring.

14.Preparation and updation of the standard operating procedure.

Involved in commissioning, validation and qualification of newly set state-of-art facility.

Hands on experience on the installation, operational and performance qualification of all the machines.

Audit faced WHO, ISO 9000, UNICEF, PANAMERICA and ROW.

I am well conversant in filling following lyophilized viral vaccines.

Measles vaccines

Measles mumps rubella vaccines

Rubella vaccines

Measles rubella vaccines

EXPERIENCE:From Jan. 95 to Jan 2003 with m/s Concept Pharmaceuticals ltd. Aurangabad as their Production Officer.

EXPERIENCE INCLUDES

1.Worked as sectional head of manufacturing, filling and packaging of injections.

2.Looking after overall production activities including manufacturing, sterilization, filling, inspection, labeling and packaging.

3.Manufacturing of small volume parenterals, viz liquids and dry sterile powder injections.

4.Hands on experience on operation of automatic/ semi-automatic, liquid vial, ampoules and dry powder injection machines.

5.Responsible for monitoring day-to-day production planning and its execution.

6.Preparation of WIP, monthly stock statement reports.

7.Preparation and updating the standard operating procedures and working product manuals.

8.Responsible for conducting various training programs in the plant in view of the gmp and on the job trainings

9.Responsible for overall good manufacturing practices in the dept.

10.Co-ordination with various dept.

11.Documentation of parentrals as per WHO, ISO 9000, ROW and their audits.

12.Validation of equipments.

BIOTECH FORMULATION WORK EXPERIENCE:1. Experience in lyophilized viral vaccine mfg & filling like MMR, Meseale, Meseale+Rubela, Rubella, Mumps vaccine.2. Worked in Biosimilars which includes Insulin, Glargine & Erythropoietin formulations filled in various formats like Vials, Prefilled Syringes & Cartridges.3. Faced various audits like Anvisa, Peru, Mexico, GCC, Gulf, Africa audits for biotech Formulation approvals.

ACHIEVEMENTS DURING THE EXPERIENCE

1.Increase in the productivity by proper training to the manpower and preventive maintenance of machines.

2.Developed proper documents and batch manufacturing records for all products.

3.Developed new Formulations.

4.Man power reduction.

5.Cost reduction in Formulations.

6.Cost reduction in process.

7.Risk mitigation for Equipments.

8.Cost reduction in CCPC of units.

9.Yield improvement in products.

10.Reduction in waste during packing & mfg stages.

EDUCATIONAL and professional ACHIVEMENTS:

1.FDA approved in Injectable manufacturing.

2.Best performance award in concept Pharma. Ltd.

3.Best ZII (zero investment implementation) award.

4.Best award for support to R&D.

5.Best Performance award in Wockhardt Pharma Ltd.

6.Best Suggestion Award.

SALARY DRAWN: RS PA.

REPORTING TO: Chief Technical Officer,

EXTRA CURRICULAR ACTIVITIES:

1.Played at National level in Hockey.2.Active participation in all the activities.

CORRESPONDENCE ADDRESS:Sindurvadan ApartmentFlat no-01, n-2, Cidco, Mahalaxmi chowk,At post, Dist: AurangabadMaharashtra (India)Mob: 9823263331

PLACE: DATE:

KIRAN DESHMUKH