Sunil Resume manufacturing 11.04.15

Application for suitable post in Manufacturing/Technology transfer in

pharmaceutical industry Sunil I. Sawant Shivanjali Nivas, Near Shraddha hospital, Shrikrishanagar Pimple Gurav Pune 411061 (Maharashtra)Contact: +919890279806; Email: [email protected]

OBJECTIVE:A post graduate in Pharmaceutics (M. Pharm) and master in business administration (MBA operations) Seeking a challenging, rewarding & responsible position in Production / Technology affair/transfer in reputed Pharmaceutical Organization, which recognizes my true potential & effectively utilizes/nurtures my excellent analytical & technical skills.

SUMMARY OF SKILLS: Conceptually strong in the field of Pharmaceutical Formulation Technology/ Tech transfer/ Quality

assurance methods. Conceptually strong with an innovative and analytical & systematic approach to the work with an

eye for detail. Enriched with the ability to learn new concepts & technology within a short span of time.

Result oriented professional with a matured approach with managerial exposure and able to make an effective contribution to the performance of a team with good leadership and motivating capabilities.

An effective team player with exceptional planning and execution skills coupled with a systematic approach and quick adaptability.

EXPERIENCE: 17+ years of experience in manufacturing of Pharmaceutical formulation in various dosage

forms like Tablets, Capsules as well as liquid Orals. Experience in technology transfer of products from R&D as well as contract manufacturers.

Monitoring the activities of scale up, scale down, process optimisation, process evaluation and validation.

Leading various transfer projects of solid dosage forms (Tablets and Capsules) from contract manufacturers like Pfizer, Mylan, Teva for regulated countries and Emcure own ANDA projects.

EDUCATIONAL CREDENTIALS: 1. Bachelor of Pharmacy

First class ( 71.23 % ) from Shivaji University

2. Master in pharmacy (Pharmaceutics) from Pune University

First class (65.4%) from Pune university

3. Master in Business Administration (MBA Operations) from IIBM Pune.

August 2008 to Oct 2010 with first class (A grade)

mailto:[email protected]



CURRENT ASSIGNMENT:Currently working with EMCURE PHARMACEUTICALS LTD. Hinjwadi, Pune since from June.2007

as Sr. Manager Manufacturing

COMPANY PROFILE:

EMCURE Pharma. Ltd. Hinjwadi Pune, is state of art facility an Indian Multinational Company

having its subsidiary co. in USA and API formulation plants nearby Pune. This plant is approved by

regulatory agencies like US FDA, UK MHRA, MCA south Africa, WHO Geneva. It is mainly engaged

in manufacturing of products from US Multinational Co. like TEVA USA, PFIZER USA, MYLAN, also

the company having its own arrangement for manufacturing and marketing its own products to

regulatory countries.

CURRENT RESPONSIBILITIES:

Manufacturing:

1. Responsible for manufacturing activities in General Block and immunosuppressant Block.

2. Planning including monthly/weekly/daily planning of activities up to execution level. Responsible

for day to day productivity.

3. Responsible for capacity utilization of the facility by using optimum resources.

4. Keeping track with engineering and support functions departments for follow up of pending and

ongoing activities

5. Responsible for improvements on shopfloor i.e. for standardization of process time reduction

scrap value, reduction in water consumptions etc.

Projects:

6. Involved in selection of machine required for manufacturing. Mainly activities are preparation of

URS, discussion with manufacturer, conducting FAT activities.

Various machines ordered are,

Korsch compression machine,

ZRO 200T capsule filling machine

IMA checkweigher




FBP-500C Pam wruster coater

Octa/Conta Blender

7. Responsible for Qualification of facility and equipments

Technology Transfer:

8. Responsible for technology transfer of products activities like

i. Coordination with CG/R&D

ii. Involved and monitoring the activities of scale up, scale down, process optimisation,

process evaluation and validation.

iii. Checking of master documents like MFR/BMR/BPR and protocols

iv. Provide the technical support for transfer of own R&D products going from selection of

equipments, any process improvements.

9. Leading the various projects for technology transfer of products from various contract

manufacturers like TEVA, Pfizer, Mylan and Emcures own ANDA products.

10. Responsible for investigation of process related deviations and failures in routine production

activity. Detailed investigations to be carried out to find out the root cause and decide the CAPA

actions.

11. Responsible for investigation of market complaints, failure investigations and investigations

related to OOS, OOE.

12. Handling, monitor and control the documents like change control, deviation, discrepancy, failure

investigation, market complaints, CAPA, Incidence report etc.

13. Responsible for checking the effectiveness of CAPA actions and compliance of self inspection

audits, regulatory audits and any technical audits pertaining to contract givers. Also fulfil the EHS

requirements.

14. Responsible for Qualification of equipments/instruments and process validation.

15. Compliance to cGMP. To check quality systems in production department

16. To ensure Good Manufacturing practices in all production functions as per regulatory guidelines.

17. To develop such type of procedures to avoid deviation in production department.




18. Handled various projects of capsules and tablets mainly for potent drugs (Containment system).

Actively participated going from selection of process equipments, plant layout with respective to

the logical flow of materials layout of AHU system.

19. Certified trainer for delivering the technical training.

20. Lead the production training team and responsible for giving training to all technical staff related

to technical improvements/ critical SOPs/ C-GMP modular training and CAPA training as well.

PREVIOUS EXPERIENCE:

1. I had 9 years of vast professional experience from reputed organization OMNI PROTECH DRUGS

LIMITED BHOSARI PUNE from 1997 to 2006.

Hands on shop floor experience for monitoring production activities related to tablet,

Capsule and liquid orals.

FDA Maharashtra approved for Capsule and Liquid Oral section.

Actively participated in ISO activities and awarded for the same.

Worked as a core team member for SAP activities in company.

Well aware and worked in qualification activities.

Worked from pharmacist to officer level.

2. I had 1.5 years of professional experience from reputed organization NIRAMAYA ETHICALS

PRIVATE LIMITED JEJURI PUNE from 2006 TO 2007

Planning and monitoring of productions functions related to Tablet and Capsule.

Involved in tech transfer and formulation development activities.

Responsible for Qualification of equipments/instruments and process validation.

Compliance to cGMP. To check quality systems in production department.




KEY SKILLS AND WORKING EXPERIENCE:

1. Worked for tech transfer activities and involved in process optimisation, evaluation and validation

activities.

2. Well aware with the regulatory audits like USFDA, UKMHRA, WHO-Geneva, ANVISA Brazil. Hands

on experience for facing these audits.

3. Experience in Tablet, capsule and Liquid oral Department and FDA Maharashtra approval for

Capsule and Liquid Oral dosage form.

4. Attended the training programme for train the trainer and certified as trainer.

5. Well aware with regulatory requirements of various agencies.

6. Conceptually strong in the field of Pharmaceutical Formulation Technology

7. Experience and worked with production planning and control dept.

8. Well aware with SAP related activities and worked as production coordinator of SAP.

9. Completed training of SAP and worked with SAP system for PRODUCTION functions.

10. Involved in technology transfer of products from R&D as well as contract manufacturers.

Monitoring the activities of scale up, scale down, process optimisation, process evaluation and

validation.

11. Monitor the Qualification, Re-qualification of equipments and instruments.

12. Prepare/revise SOP, Master Document and Production procedures as and when required.

13. Lead the production training team and responsible for giving training to all technical staff related

to technical improvements/ critical SOPs/ C-GMP modular training and CAPA training as well.

14. Attended various training technical programmes, pharmaceutical conferences as well as team

building sessions from various consultancies.

15. Well aware with conducting the FAT of machinery at various manufacturers.




ACHIEVEMENTS:

1. Worked for tech transfer activities and involved in process optimisation, evaluation and

validation activities.

2. Independently handled and set up investigation and documentation section.

3. Working experience in Tablet, Capsule and liquid orals sections.

4. Lead the training team and responsible for conducting the technical training.

5. Well aware with regulatory requirements of various agencies.

6. FDA Maharashtra approval in Capsule and Liquid Orals section.

7. Completed training on SAP and worked with SAP system for Production functions

8. Hands on experience for preparation of documents like MFR/BMR/BPR, SOP, and Validation

protocols etc.

9. Attended various training of Machine manufacturers like Capsule filling machine(AF90T),

Compression Machine Legacy6100, Sejong compression machine, BOSCH check weighing

system.

COMPUTER SKILL :1. Well aware with MS-office software fluently using all functions related with office software’s like

Excel, Word, PowerPoint etc.

2. Well aware with SAP system and worked with execution level.

PERSONAL INFORMATION: Date of Birth : 06th May 1976 Nationality : Indian Language Proficiency : English, Hindi & Marathi. Sex : Male Marital status : Married

Thanking You,

Mr. Sunil Ishwar Sawant


Sunil Resume manufacturing 11.04.15

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