SUNIL D KUTE

A-*/***, Adhyay, kanchanpushpa Complex,

G.B.Road. Thane (west) - 400615

CONTACT: 981-***-****

E MAIL: ac9ou0@r.postjobfree.com

OBJECTIVE

To seek a senior role in Technical Services /production function of pharmaceutical organization in the domain of solid oral dosage form to provide solutions to business challenges.

PROFILE SUMMARY:

Key Experience: Over 12 years of experience in Oral solid dosage form operations i.e. manufacturing and packing operations of Coated / Uncoated tablets, capsules formulation and encapsulation, Dry Powder syrup and bottle filling operation intended for regulated market.

Over 5 years of experience in Technical Services function with key deliverables like Troubleshooting Management system designing and implementation. Complaints Investigation and CAPA tracking. Overall Knowledge of empty hard gelatin capsules processing.

Relationship Management: Build and strengthen relationships with key accounts, and opinion leaders. Close co-ordination with the M D, Director Marketing, Regional Sales Managers, Product Managers and Zone heads, ensuring smooth and profitable operations. Identifying and networking with financially strong and reliable channel partners, resulting in deeper market penetration and reach.

Sales Promotion: Developing and appointing new business partners to expand product reach in the market and working in close interaction with the dealers and distributors to assist them to promote the product.

Field: Pharmaceutical

Qualification: Diploma in Mechanical Technology

CORE COMPETENCIES:

Quality Management system,

Process Validation,

Equipment Qualification.

Complaint investigations, Cause & effect diagram, 5 why analysis, Failure mode effect analysis.

Investigation report.

Risk Assessment study.

Corrective & Preventive action tracking mechanism

Customer and Regulatory Audits, Compliance reporting and Closure

Granulation.

Tablet Compression,

Tablet coating (film / Enteric),

Empty Hard gelatin capsule manufacturing,

Formulation and Encapsulation in high speed filling machines.

ORGANIZATIONAL EXPERIENCE:

Natural Capsules Limited. July'2017 till Date

Manager (Technical Services to CEO)

Natural capsules are second largest manufacturer of Empty Hard Gelatin capsule shells in India. Manufacturer of Wide range of Capsule products like Gelatin capsule, Cellulose capsule, Liquid fill capsules, Pearl Capsules, Stick free capsules for Dry Powders for Inhalation, Four Color Printing on capsules for Brand shielding of customer products.

Attended customer compliant & visit pro-actively to customer.

Monthly Review of Plant performance with the promoters.

Arrange online or offline training for customer, Regarding Encapsulation & Troubleshooting.

Compliance to Statutory and Regulatory requirements Ensure.

Initiate and implement strategic moves towards continual improvements.

People Development.

Complaint Management System.

Development of employees.

ACG Associated Capsules Pvt. Ltd. November’2015 to Jun’2017

Senior Officer (Technical services Department head)

Associated Capsules is a part of ACG worldwide group company having diversified business in Pharmaceutical business operations. ACG has an integrated approach to serve Pharma industry, manufacturers of Empty hard capsules (Gelatin and Cellulose), Capsule filling machine, Tablet press and Tablet tooling, Blister packing machine, Carton packing machines, barrier packaging PVC, PVDC, laminates for packaging in solid oral dosage form. Camera inspection system. ACG has its network spread in more than 50 countries.

Attended customer compliant & visit pro-actively to customer.

Monthly Review of Plant performance with the promoters.

Arrange online or offline training for customer, Regarding Encapsulation & Troubleshooting.

Compliance to Statutory and Regulatory requirements Ensure.

Initiate and implement strategic moves towards continual improvements.

People Development.

Complaint Management System.

Development of employees..

LUPIN LIMITED April’2013 to October’2015

Officer Production

To ensure smooth functioning of day to day activities with complying with cGMP norms.

Implementation of cGMP, Safety and productivity in equipment.

Attending and planning of preventive maintenance schedule.

Attending and planning of troubleshooting and breakdown.

Good ability of machine setting and breakdown handling.

Co-ordination with production& engineering planning and Q.A department.

Machinery installation as per cGMP guidelines.

Trouble shootings of all equipment’s.

Track up for civil, painting, false sealing work and modifications in building..

HVAC as well as machinery installation as per cGMP guidelines.

Preventive maintenance and routine activity of engineering department.

Documents like P.M. Record and Machine History File.

On job training to the new entrant.

Maintain daily record (balance calibration & cleaning) & Tooling record (capsule machine & coating tool)

Support to validation, scale up & placebo batches & processing of commercial batches.

Modification of change part during new product development.

Maintain capsule machine change part & spare part.

Troubleshooting during running machine.

Cost saving (change part & consumable).

Team member of new project (Yield improvement & Reduce changeover time)

E-Log, SCADA, BMR complies.

Inventory of Silicon and Marprene Tube.

Change Parts Issuances.

BMR review

Handling of coating machine & Capsules Machine Change Parts .

Calibrations of Weighing Balances, Stop Watch, Vernier Caliper through External Agency.

To Maintain Inventory of Coating Department.

Ensure Zero Line Clearances Failure.

To Complete SABA Trainings within Stipulated Timelines.

Maintain CAPAs & SOP’s in Department.

CIPLA LTD. Jun’2012 to April’2013

Management Staff (Production)

To ensure smooth functioning of day to day activities with complying with cGMP norms.

Implementation of cGMP, Safety and productivity in equipment.

Attending and planning of preventive maintenance schedule.

Attending and planning of troubleshooting and breakdown.

Good ability of machine setting and breakdown handling.

Co-ordination with production& engineering planning and Q.A department.

Machinery installation as per cGMP guidelines.

Trouble shootings of all equipment’s.

Track up for civil, painting, false sealing work and modifications in building..

HVAC as well as machinery installation as per cGMP guidelines.

Preventive maintenance and routine activity of engineering department.

Documents like P.M. Record and Machine History File.

On job training to the new entrant.

Dr.Reddy’s Lab December’2010 to Jun’2012

Junior officer (Production)

To ensure smooth functioning of day to day activities with complying with cGMP norms.

Implementation of cGMP, Safety and productivity in equipment.

Attending and planning of preventive maintenance schedule.

Attending and planning of troubleshooting and breakdown.

Good ability of machine setting and breakdown handling.

Co-ordination with production& engineering planning and Q.A department.

Machinery installation as per cGMP guidelines.

Trouble shootings of all equipment’s.

Track up for civil, painting, false sealing work and modifications in building..

HVAC as well as machinery installation as per cGMP guidelines.

Preventive maintenance and routine activity of engineering department.

Documents like P.M. Record and Machine History File.

On job training to the new entrant.

Ajanta Pharma Ltd. May'2002 to December2010

Technician (Production)

To ensure smooth functioning of day to day activities with complying with cGMP norms.

Implementation of cGMP, Safety and productivity in equipment.

Attending and planning of preventive maintenance schedule.

Attending and planning of troubleshooting and breakdown.

Good ability of machine setting and breakdown handling.

Co-ordination with production& engineering planning and Q.A department.

Machinery installation as per cGMP guidelines.

Trouble shootings of all equipment’s.

Track up for civil, painting, false sealing work and modifications in building..

HVAC as well as machinery installation as per cGMP guidelines.

Preventive maintenance and routine activity of engineering department.

Documents like P.M. Record and Machine History File.

On job training to the new entrant.

EDUCATION AND CREDENTIAL

Diploma in Mechanical Technology – IIET (Hyderabad) – 2011

HSC-Nashik-2001

SSC-Nashik-1999

TRAINING AND DEVELOPMENT

Effective Personal Productivity program of Leadership Management International.

Business Writing Skills.

Leading Self Leading Team.

First Aid / Safety.

PERSONAL PROFILE

Name: Sunil Dattu Kute

Date of Birth: 17th Jun 1983

Nationality: Indian

Passport No: Z3900170

DECLARATION

I, hereby declare that all the statements made above are true & correct to the best of my Knowledge and belief.

Place: Mumbai SUNIL KUTE

Date: Mob. No. 981-***-****

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