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Quality Assurance Management

Location:
Vani, India
Salary:
4 to 6 Lakhs
Posted:
May 08, 2011

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Resume:

KULKARNI SANJAY WASUDEORAO

Mobile: +91-860******* / Phone (Res.): 025********

E-Mail: vxrjy7@r.postjobfree.com

MANAGEMENT PROFESSIONAL

Formulation/Production Operations ~ New Product Development

Professional Synopsis

Approved Chemist offering more than 25 years of strong, decisive executive leadership with proven abilities to improve the production process/ operation, optimize resource & capacity utilization, maximise productivity & operational efficiencies; while curtailing costs & expenses across Pharmaceuticals Industries. Conversant with techniques like Value Engineering & Value Analysis, Total Productive Maintenance. Well conversant with TQM, Regulatory requirements / documentation, safety & environment protection. Proven abilities in managing technically advanced, cost-efficient systems and processes.

Resourceful in interfacing with the Pollution Control Board, Govt Depts. for various Certifications, Approvals, Audits, Clearances, etc. Ensuring compliance to quality standards and maintaining all related documents. The wealth of expertise covers:

Plant Operations Production Management & Planning Process Enhancement

Project Management Cost Optimization Resource Deployment

Lab Operations Quality Assurance & Control Yield Improvement

Equipment Utilization Requirement Planning Documentation

New Product Development Procurement / Vendor Management EHS Operations

Exceptionally well organized with a track record that demonstrates self motivation, creativity, and initiative to achieve corporate goals..

Areas of Expertise

1 Production Management: Developing products; executing production and manpower schedules / plans for smooth execution within time & cost parameters. Delegating work schedules; preparing & implementing the SOP guidelines; leading & monitoring performance of team to ensure efficiency in operations. Investigating the out of specification results, process validation & cleaning validation,

2 Product/ Process Improvement: Generating schedules for routine maintenance, calibration and troubleshooting. Conducting preventive maintenance, foreseeing performance bottlenecks and taking corrective measures to achieve timely deliveries of quality products, for full customer satisfaction

3 Regulatory Affairs: Preparing specifications/ SOPs and regulatory documentation. Undertaking analytical method validation as per pharmaceutical regulations (GMP) and various regulatory authorities.

4 Research & Development: Searching literature on new products (e.g. Beilstein, Chemical Abstacts, Treatises, Original journals, etc.). Selecting the most promising synthetic route to the desired product. Verifying / studying / optimizing reactions to define the process. Troubleshooting of problems in chemical production. Providing technical support to production.

5 Resource Management: Identifying and developing potential vendors / suppliers achieving reduction in prices & timely delivery. Managing & monitoring the performance of team members to ensure efficiency in the various process operations. Imparting training to the workmen on cGMP system & batch manufacturing process.

Career Contour

Novartis Singapore Pharmaceutical Manufacturing, Singapore - Process Technician Feb’08-Oct’10

Major Accomplishments

6 Involved in controlling In Process Checks in tabletting area.

7 Effectively managed the whole activity in the absence of the co-ordinator when demanded.

8 Served as a Subject Matter Expert In Granulation Area.

9 Worked in different modules like charging, dispensing under MES control.

10 Worked in a company, having USFDA facility, which has faced extensive audits from PMDA, USFDA, EU.

GlaxoSmithKline Pharma, Nasik Apr’89-Feb’08.

Growth Path:

Manufacturing Skilled Staff Grade 2 Apr’89-Dec’01

Skilled Staff Grade 1 Jan’02-Feb’08

Performed a role of acting Management executive in the shift operations for a period of more than seven years in Tablets.

Major Accomplishments

11 Involved in the manufacturing of

Betamethasone sodium phosphate products. Production of Betnesol & Betnelan tablets includes the usage of planetary mixer, Fluid Bed Dryer, Co-mill for processing of granules; compression on Cadmach Double Rotary Compression m/c’ s, 35 & 45 Stations.

Zinetac 150 & 300mg Coated Tablet. Zinetac is a Ranitidine Hydrochloride product. Manufacturing of Zinetac involves dry granulation in a double cone blender. Compression is carried out on Cadmach CTX-32 (32 Stations) and coating is carried out on Manesty make 'Accelacota' coating pans.

Commenced career Maharashtra Antibiotics & Pharmaceuticals Ltd, (worked as an Apprentice from Jan'1983 toJuly'84), Production Technician - july'84-apr'89

Scholastic

B.Sc. from Nagpur University in 1982.

Professional Training Attended:

12 Self Development Programme in Pharmaceutical Environment.

13 Attended sessions on safety, Environment Protection & Waste Water treatment

14 Employee awareness programmes.

15 Inprocess control of tablets.

16 Creation of SOP’s and Work Instructions.

17 CGMP, SOP, Manufacturing instructions.

18 Documentation & Maintenance of routine records according to FDA.

19 Technical Training

20 Glaxo Excellence Process Training.

21 Operational Excellence Advocate Training.

22 Various modules of Seer Pharma Training. (Australia)

23 Train the Trainer Programme.

Personal Dossier

Address : Flat No. 6, Sonam Socy, Rajiv Nagar, Nasik-422009, Maharashtra.

Date of Birth :28/03/1961

Languages : English, Marathi & Hindi

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