RESUME
Mr. Naga Raju Manne
Correspondence Address: E-Mail address:
Srinivas Manne. Rustumbada, Krishnababu colony *************@*****.*** Narasapuram 534275 W.G.Dt., Andhrapradesh (INDIA)
Mobile: +966*********, +918*********
PROFILE:
graduate and Technical Diploma with 22yrs. of hand on experience in defferent dosages Tablets Ointment
&Oral liquid manufacturing, filling areas. Well conversant with USFDA, UKMHRA, WHO Guidelines, SFDA and ISO while working with reputed Pharma and cosmotic companies. Presently working with National Pharmaceuticals, Riyadh (KSA) as Production supervisor in Operations from Aug. 2015 in Oral, Semi solids and liquids Dosage . CAREER OBJECTIVES:
To have challenging career opportunities in Plant that will utilize my professional affiliation & update my knowledge in reputed pharmaceutical organization
BEHAVIORAL/ MANAGERIAL SKILLS
- Strong analytical skills, leadership abilities, strong negotiation skills with ability to strategize.
- Exposure of handling large teams with multicultural background
- Good communication skill
TECHNICAL/ FUNCTIONAL SKILLS
- Scale up and manufacturing of Solid dosage forms on large scale.
- Knowledge of cGMP .
- Product troubleshooting and technology transfer at plant level.
- Knowledge of ISO 9001 and ISO 14001..
- Well versed with Automated lines and equipments used in formulations PRESENT JOB RESPONSIBILITIES:
In charge of production operations (as a supervisor) and Quality improvement.
Leading and managing a team comprising the head of departments of Production and Packaging.
Responsible for entire manufacturing and packaging operations of semi solid and disinfectant dosage facility.
Lead the scale up of products from Pilot plant to the production facility by working closely with development team, facilitate transfer of process and its documentation.
Preparation of URS for all manufacturing and packaging equipments.
All area and equipment cleaning and operation SOP’s, flow charts, Protocols preparation, approval and execution.
Responsible for lead the production plan and scheduling activities, and deliver the products as per market requirements.
Responsible for monitoring day to day operations towards the objective of continuously improving the performance metrics.
Ensuring compliance to all internal and external regulatory and quality audits, process and systems inside the plant.
Evaluate and working towards cost reduction projects decided by management collectively towards operational excellence.
Coordination with all cross functional teams for smooth functioning of facility.
Resource availability co-ordinations Tooling and change parts availability. Also will follow technical guidance towards development of new products change parts.
Responsible for improving plant efficiency by minimizing breakdowns and continuous improvement.
Provide strategic directions in investigating deviations, OOS to suggest robust CAPA.
Responsible to maintain EHS requirements and implementation of safety procedures.
Actively involved in new product validation programs along with QA department.
Preparation of Master Batch Records, Validation Protocols, SOP’S.
Detailed training on production documentation and data integrity
Identifying training needs, planning and providing on job and SOP training to workers to optimize their shop floor performance and multi skilling.
Impart skills on shop floor activities and handling/balancing production lines by proper allocations and utilizing shop floor manpower.
Prepare and review of SOP’s, batch documents and related formats by regular following up regarding production planning,weekly,fortnightly and monthly reviews.
Monitoring production activities strictly adhere to the quality aspects.
Production related SOP, protocols, flowcharts.
Production Compliance of internal and external Regulatory and quality audits.
Deviation Reports and Investigation Reports.
Achievements while working with National pharma
- Trained the operators as best team
- Increased production output almost double with proper manpower and machine management. Achievements in overall career:
Successfully faced USFDA, MHRA, SFDA and ISO audit without any critical observation.
Modification of manufacturing procedure resulted in increased productivity.
Yield improvement by identifying and controlling process loss at different stages of manufacturing. INDUSTRIAL EXPERIENCE:
Worked with Avalon Pharma as a team leader as well as operations from Octber 2008 to May 2015
Responsible for all production machines operations in manufacturing compliance of plant.
Responsible for the Quality product with Quantity.
Responsible for the commitment.
Follow the delivery schedule according to monthly plan.
Responsible to the bottleneck the capacity to meet increased market requirement.
Co-ordination with new/existing product analytical development team for development of new product testing specification and quality system
Ensure that operations are performed as per established SOPs, and the collection and maintenance of data are performed in accordance with cGMP, company standards, safety guidelines, policies and other regulatory requirements.
Actively involved in new product validation programs along with QA department
Recognization in the plant as a best Employee during my work period. Worked with DR. . Reddy's Laboratories Ltd., Bachupally Hyderabad (FTO-3 Generic Unit USFDA) as a Production Sr. Technician in SOLID Orals manufacturing facility from March .2004 to Sep. 2008 Job Responsibilities_
Production Technician of Tablet Manufacturing activities.
Production Operation and it's realization with targeted time.
Responsible for the productive breakdowns at the process equipment.
Process development, monitoring & improvement of yields and recoveries, monitoring quality aspects.
Implementation, development, troubleshooting & scale up of new product batches.
Monitoring production activities strictly adhere to the quality aspects.
Activ participation In USFDA, UKMHRA & WHO Audits.
Recognization in the plant as a best Technician.
Compliance of Production related SOP, protocols, flowcharts. Worked with Dr. Reddy's Laboratories Ltd., Bachupally Hyderabad Branded Formulations FTO Unit II and Unit IV ) as a Junior Technical Officer from Apr.2001 to Feb.2004 Job Responsibilities_
Production Technician of Tablet Manufacturing activities.
Production Operation and it's realization with targeted time.
Responsible for the productive breakdowns at the process equipment.
Process development, monitoring & improvement of yields and recoveries, monitoring quality aspects.
Implementation, development, troubleshooting & scale up of new product batches.
Monitoring production activities strictly adhere to the quality aspects.
Activ participation In USFDA, UKMHRA & WHO Audits.
Have a great experience while working in UNIT- IV as SMT (Self Management Team)
Compliance of Production related SOP, protocols, flowcharts.
Actively involved in new product validation programs along with QA department.
Preparation of Master Batch Records, Validation Protocols, SOP’S..
PERSONAL DETAILS :
Date of birth : 15-04-1980
Marital status: Married.
Children : Two
EDUCATION :
Bachelors Degree from Himalayan University India,
Diploma in Mechanical EngineeringFrom State Board of Technical Education in 2000 I hereby declare that all the information furnished above is true to the best of my knowledge and belief.
Naga Raju Manne.